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sotorasib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Ras protein inhibitors | 5461 | 2296729-00-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sotorasib is an inhibitor of KRASG12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRASG12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS. Sotorasib blocked KRAS signaling, inhibited cell growth, and promoted apoptosis only in KRAS G12C tumor cell lines. Sotorasib inhibited KRASG12C in vitro and in vivo with minimal detectable off-target activity. In mouse tumor xenograft models sotorasib-treatment led to tumor regressions and prolonged survival and was associated with anti-tumor immunity in KRAS G12C models.
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 |
|---|---|---|---|---|---|
| kinase-safety-class | EIF2AK3,PDK1,PDK2,PDK4 | 4 | |||
| kinase-selectivity-class | BMX | 1 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 14.655 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.006 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 28, 2021 | FDA | AMGEN INC | |
| Jan. 6, 2022 | EMA | Amgen Europe BV | |
| Jan. 20, 2022 | PMDA | AMGEN K.K. |
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 |
|---|---|---|---|---|---|---|
| Non-small cell lung cancer | 344.62 | 49.70 | 58 | 1132 | 4323 | 90622934 |
| Non-small cell lung cancer metastatic | 200.50 | 49.70 | 29 | 1161 | 789 | 90626468 |
| Diarrhoea | 99.75 | 49.70 | 88 | 1102 | 939102 | 89688155 |
| Death | 94.99 | 49.70 | 64 | 1126 | 456487 | 90170770 |
| Hepatotoxicity | 92.18 | 49.70 | 31 | 1159 | 45811 | 90581446 |
| Alanine aminotransferase increased | 66.75 | 49.70 | 32 | 1158 | 118306 | 90508951 |
| Aspartate aminotransferase increased | 64.70 | 49.70 | 30 | 1160 | 102907 | 90524350 |
| Hepatic function abnormal | 61.39 | 49.70 | 23 | 1167 | 46265 | 90580992 |
| Therapy partial responder | 60.94 | 49.70 | 19 | 1171 | 22024 | 90605233 |
| Disease progression | 58.27 | 49.70 | 32 | 1158 | 156583 | 90470674 |
| Hepatic cytolysis | 50.79 | 49.70 | 18 | 1172 | 30898 | 90596359 |
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 |
|---|---|---|---|---|---|---|
| Non-small cell lung cancer | 852.14 | 41.51 | 147 | 1336 | 4827 | 42615025 |
| Non-small cell lung cancer metastatic | 234.85 | 41.51 | 38 | 1445 | 805 | 42619047 |
| Hepatic function abnormal | 136.01 | 41.51 | 55 | 1428 | 51512 | 42568340 |
| Death | 85.06 | 41.51 | 92 | 1391 | 471093 | 42148759 |
| Diarrhoea | 77.91 | 41.51 | 87 | 1396 | 460762 | 42159090 |
| Disease progression | 61.67 | 41.51 | 46 | 1437 | 143610 | 42476242 |
| Lung adenocarcinoma | 60.06 | 41.51 | 17 | 1466 | 5322 | 42614530 |
| Aspartate aminotransferase increased | 50.28 | 41.51 | 32 | 1451 | 77131 | 42542721 |
| Metastases to central nervous system | 45.14 | 41.51 | 16 | 1467 | 10339 | 42609513 |
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 |
|---|---|---|---|---|---|---|
| Non-small cell lung cancer | 852.93 | 43.12 | 145 | 2003 | 7790 | 110579361 |
| Non-small cell lung cancer metastatic | 275.70 | 43.12 | 43 | 2105 | 1309 | 110585842 |
| Disease progression | 205.64 | 43.12 | 98 | 2050 | 243936 | 110343215 |
| Death | 135.94 | 43.12 | 110 | 2038 | 698759 | 109888392 |
| Diarrhoea | 130.58 | 43.12 | 133 | 2015 | 1139372 | 109447779 |
| Hepatic function abnormal | 127.16 | 43.12 | 52 | 2096 | 89243 | 110497908 |
| Lung adenocarcinoma | 97.97 | 43.12 | 25 | 2123 | 9506 | 110577645 |
| Aspartate aminotransferase increased | 86.99 | 43.12 | 48 | 2100 | 159888 | 110427263 |
| Hepatic cytolysis | 81.48 | 43.12 | 33 | 2115 | 55020 | 110532131 |
| Therapy partial responder | 79.09 | 43.12 | 29 | 2119 | 37032 | 110550119 |
| Alanine aminotransferase increased | 75.58 | 43.12 | 46 | 2102 | 183727 | 110403424 |
| Hepatotoxicity | 54.67 | 43.12 | 26 | 2122 | 63374 | 110523777 |
| Cholestasis | 54.24 | 43.12 | 26 | 2122 | 64492 | 110522659 |
| Lung neoplasm malignant | 45.65 | 43.12 | 19 | 2129 | 33823 | 110553328 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX73 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D000970 | Antineoplastic Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic 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 |
|---|---|---|---|
| KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer | indication | 254637007 | DOID:3908 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 12280056 | Nov. 18, 2039 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 12280056 | Nov. 18, 2039 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 12280056 | Nov. 18, 2039 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11236091 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11827635 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 12398133 | May 20, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | 11426404 | Sept. 15, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | May 28, 2026 | NEW CHEMICAL ENTITY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | Jan. 16, 2028 | IN COMBINATION WITH PANITUMUMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER AS DETERMINED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | Jan. 16, 2028 | IN COMBINATION WITH PANITUMUMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER AS DETERMINED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | Jan. 16, 2028 | IN COMBINATION WITH PANITUMUMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER AS DETERMINED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | May 28, 2028 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | May 28, 2028 | 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) |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | May 28, 2028 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| 120MG | LUMAKRAS | AMGEN INC | N214665 | May 28, 2021 | RX | TABLET | ORAL | Jan. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-AND IRINOTECAN-BASED CHEMOTHERAPY |
| 240MG | LUMAKRAS | AMGEN INC | N214665 | June 26, 2024 | RX | TABLET | ORAL | Jan. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-AND IRINOTECAN-BASED CHEMOTHERAPY |
| 320MG | LUMAKRAS | AMGEN INC | N214665 | Jan. 20, 2023 | RX | TABLET | ORAL | Jan. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-AND IRINOTECAN-BASED CHEMOTHERAPY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GTPase KRas | Enzyme | INHIBITOR | IC50 | 7.03 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D12055 | KEGG_DRUG |
| 2B2VM6UC8G | UNII |
| C5418250 | UMLSCUI |
| CHEBI:178199 | CHEBI |
| CHEMBL4535757 | ChEMBL_ID |
| 137278711 | PUBCHEM_CID |
| DB15569 | DRUGBANK_ID |
| 11370 | INN_ID |
| C000706028 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10678 | IUPHAR_LIGAND_ID |
| 1162482008 | SNOMEDCT_US |
| 1162509004 | SNOMEDCT_US |
| 4040545 | VANDF |
| 347100 | MMSL |
| 39561 | MMSL |
| d09751 | MMSL |
| 018747 | NDDF |
| 2550714 | RXNORM |
| 2B2VM6UC8G | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LUMAKRAS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-488 | TABLET, COATED | 120 mg | ORAL | NDA | 30 sections |
| LUMAKRAS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-504 | TABLET, COATED | 320 mg | ORAL | NDA | 30 sections |
| LUMAKRAS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-512 | TABLET, COATED | 240 mg | ORAL | NDA | 30 sections |