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selinexor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| nuclear export inhibitors | 5330 | 1393477-72-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1(XPO1)
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.436 | Moderate | 0.75 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.076 | Moderate | 0.75 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 54.576 | 10^-6 cm/s | Moderate | 0.75 |
| dh-clint | Dog hepatocyte intrinsic clearance | 5.176 | uL/min/10^6 cells | Moderate | 0.75 |
| dppb | Dog plasma protein binding (% unbound) | 4.880 | % | Moderate | 0.75 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 8.380 | % | Moderate | 0.75 |
| herg | hERG pIC50 | 4.735 | pIC50 | Moderate | 0.75 |
| hh-clint | Human hepatocyte intrinsic clearance | 3.750 | uL/min/10^6 cells | Moderate | 0.75 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.963 | uL/min/mg protein | Moderate | 0.75 |
| hppb | Human plasma protein binding (% unbound) | 2.890 | % | Moderate | 0.75 |
| kinase-safety-class | ACVR2B,AXL,EIF2AK3,GRK2,PDK1,PDK2,PDK4,PRKDC | 8 | |||
| kinase-selectivity-class | AXL,EIF2AK3 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 7.379 | Moderate | 0.75 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 22.961 | Moderate | 0.75 | |
| mppb | Mouse plasma protein binding (% unbound) | 4.660 | Moderate | 0.75 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 6.471 | Moderate | 0.75 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 | |||
| pppb | Pig plasma protein binding (% unbound) | 6.870 | % | Moderate | 0.75 |
| rh-clint | Rat hepatocyte intrinsic clearance | 9.772 | uL/min/10^6 cells | Moderate | 0.75 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 27.180 | % | Moderate | 0.75 |
| rppb | Rat plasma protein binding (% unbound) | 4.160 | % | Moderate | 0.75 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 10.162 | uM | Moderate | 0.75 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 26, 2021 | EMA | Karyopharm Europe GmbH | |
| July 3, 2019 | FDA | KARYOPHARM THERAPEUTICS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 382.01 | 50.59 | 153 | 1998 | 208572 | 90417724 |
| Nausea | 174.39 | 50.59 | 168 | 1983 | 1110148 | 89516148 |
| Myelosuppression | 113.62 | 50.59 | 44 | 2107 | 53547 | 90572749 |
| Neutropenia | 91.21 | 50.59 | 60 | 2091 | 224844 | 90401452 |
| Aeromonas infection | 67.55 | 50.59 | 10 | 2141 | 171 | 90626125 |
| Decreased appetite | 65.74 | 50.59 | 61 | 2090 | 376479 | 90249817 |
| Anaemia | 61.25 | 50.59 | 57 | 2094 | 352745 | 90273551 |
| Pneumonia | 59.36 | 50.59 | 74 | 2077 | 637985 | 89988311 |
| Vomiting | 55.84 | 50.59 | 80 | 2071 | 788213 | 89838083 |
| Platelet count decreased | 54.07 | 50.59 | 36 | 2115 | 136933 | 90489363 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 274.76 | 41.42 | 161 | 2501 | 190118 | 42428555 |
| Nausea | 138.72 | 41.42 | 145 | 2517 | 396654 | 42222019 |
| Plasma cell myeloma refractory | 94.13 | 41.42 | 21 | 2641 | 1389 | 42617284 |
| Diffuse large B-cell lymphoma refractory | 92.01 | 41.42 | 22 | 2640 | 1975 | 42616698 |
| Decreased appetite | 78.60 | 41.42 | 77 | 2585 | 193060 | 42425613 |
| Pneumonia | 71.93 | 41.42 | 108 | 2554 | 422041 | 42196632 |
| Fatigue | 63.79 | 41.42 | 104 | 2558 | 435537 | 42183136 |
| Disease progression | 63.48 | 41.42 | 60 | 2602 | 143596 | 42475077 |
| Anaemia | 58.27 | 41.42 | 79 | 2583 | 280199 | 42338474 |
| Plasma cell myeloma | 56.98 | 41.42 | 36 | 2626 | 47542 | 42571131 |
| Hyponatraemia | 51.82 | 41.42 | 46 | 2616 | 101416 | 42517257 |
| Plasma cell myeloma recurrent | 48.97 | 41.42 | 17 | 2645 | 5740 | 42612933 |
| Myelosuppression | 46.89 | 41.42 | 30 | 2632 | 40431 | 42578242 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 647.58 | 41.46 | 307 | 4391 | 348578 | 110236023 |
| Nausea | 262.58 | 41.46 | 289 | 4409 | 1235401 | 109349200 |
| Myelosuppression | 143.38 | 41.46 | 73 | 4625 | 94267 | 110490334 |
| Decreased appetite | 142.98 | 41.46 | 135 | 4563 | 475711 | 110108890 |
| Pneumonia | 136.66 | 41.46 | 176 | 4522 | 876538 | 109708063 |
| Diffuse large B-cell lymphoma refractory | 122.49 | 41.46 | 27 | 4671 | 2494 | 110582107 |
| Neutropenia | 121.48 | 41.46 | 111 | 4587 | 374509 | 110210092 |
| Anaemia | 114.81 | 41.46 | 128 | 4570 | 546958 | 110037643 |
| Disease progression | 106.93 | 41.46 | 86 | 4612 | 243948 | 110340653 |
| Hyponatraemia | 102.41 | 41.46 | 80 | 4618 | 217573 | 110367028 |
| Fatigue | 99.43 | 41.46 | 181 | 4517 | 1215777 | 109368824 |
| Platelet count decreased | 94.17 | 41.46 | 78 | 4620 | 230365 | 110354236 |
| Plasma cell myeloma recurrent | 86.01 | 41.46 | 25 | 4673 | 7017 | 110577584 |
| Plasma cell myeloma | 68.34 | 41.46 | 39 | 4659 | 62897 | 110521704 |
| Cytopenia | 62.87 | 41.46 | 29 | 4669 | 30087 | 110554514 |
| Febrile neutropenia | 62.58 | 41.46 | 72 | 4626 | 316695 | 110267906 |
| Cytokine release syndrome | 61.77 | 41.46 | 38 | 4660 | 70268 | 110514333 |
| Therapy partial responder | 54.24 | 41.46 | 28 | 4670 | 37033 | 110547568 |
| Vomiting | 54.09 | 41.46 | 119 | 4579 | 910556 | 109674045 |
| Sepsis | 52.56 | 41.46 | 67 | 4631 | 327279 | 110257322 |
| Plasma cell myeloma refractory | 52.49 | 41.46 | 13 | 4685 | 1988 | 110582613 |
| Aeromonas infection | 50.86 | 41.46 | 10 | 4688 | 527 | 110584074 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX66 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| FDA EPC | N0000194021 | Nuclear Export Inhibitor |
| FDA MoA | N0000194022 | Nuclear Export Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
| CHEBI has role | CHEBI:229763 | exportin 1 inhibitor |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
Related Drugs by ATC class:
L01XX Other antineoplastic agents 33 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapse multiple myeloma | indication | 452291000124109 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.3 | acidic |
| pKa2 | 2.61 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 10544108 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11034660 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11787771 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 12291508 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 9079865 | July 26, 2032 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 10519139 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11746102 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | 11753401 | Aug. 14, 2035 | XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | July 3, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | July 3, 2026 | IN COMBO W/ DEXAMETHASONE FOR ADULTS W/ RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO RECEIVED AT LEAST 4 PRIOR THERAPIES AND REFRACTORY TO AT LEAST 2 PROTEASOME INHIBITORS, AT LEAST 2 IMMUNOMODULATORY AGENTS, AND AN ANTI-CD38 MONOCLONAL ANTIBODY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | July 3, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | July 3, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | July 3, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | July 3, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | June 22, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | June 22, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | June 22, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | June 22, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | June 22, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 10MG | XPOVIO | KARYOPHARM THERAPS | N212306 | March 10, 2025 | RX | TABLET | ORAL | Dec. 18, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 20MG | XPOVIO | KARYOPHARM THERAPS | N212306 | July 3, 2019 | RX | TABLET | ORAL | Dec. 18, 2027 | FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY, EXCLUDING ADULT PATIENTS COVERED BY XPOVIOS PREVIOUS INDICATION FOR MULTIPLE MYELOMA APPROVED ON JULY 3, 2019 |
| 40MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | Dec. 18, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 50MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | Dec. 18, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 60MG | XPOVIO | KARYOPHARM THERAPS | N212306 | April 15, 2021 | RX | TABLET | ORAL | Dec. 18, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | XPOVIO | KARYOPHARM THERAPS | N212306 | Oct. 20, 2025 | RX | TABLET | ORAL | Dec. 18, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Exportin-1 | Nuclear other | INHIBITOR | IC50 | 7.70 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 31TZ62FO8F | UNII |
| 4038565 | VANDF |
| C3852671 | UMLSCUI |
| CHEBI:229764 | CHEBI |
| CHEMBL3545185 | ChEMBL_ID |
| 71481097 | PUBCHEM_CID |
| DB11942 | DRUGBANK_ID |
| D11222 | KEGG_DRUG |
| 9872 | INN_ID |
| C585161 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10036 | IUPHAR_LIGAND_ID |
| 788703001 | SNOMEDCT_US |
| 788710007 | SNOMEDCT_US |
| 319363 | MMSL |
| 37137 | MMSL |
| d09321 | MMSL |
| 018055 | NDDF |
| 2178390 | RXNORM |
| 31TZ62FO8F | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-101 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 28 sections |
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-102 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 28 sections |
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-103 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 28 sections |
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-104 | TABLET, FILM COATED | 60 mg | ORAL | NDA | 28 sections |
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-105 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 28 sections |
| XPOVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72237-106 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 28 sections |