Sotorasib
- Generic Name
- Sotorasib
- Brand Names
- Lumakras, Lumykras
- Drug Type
- Small Molecule
- Chemical Formula
- C30H30F2N6O3
- CAS Number
- 2252403-56-6
- Unique Ingredient Identifier
- 2B2VM6UC8G
Overview
Sotorasib, also known as AMG-510, is an acrylamide-derived KRAS inhibitor developed by Amgen. It is indicated in the treatment of adult patients with KRAS G12C mutant non-small cell lung cancer. This mutation makes up >50% of all KRAS mutations. Mutant KRAS discovered in 1982 but was not considered a druggable target until the mid-2010s. It is the first experimental KRAS inhibitor. The drug MRTX849 is also currently being developed and has the same target. Sotorasib was granted FDA approval on May 28, 2021, followed by the European Commission's approval on January 10, 2022.
Background
Sotorasib, also known as AMG-510, is an acrylamide-derived KRAS inhibitor developed by Amgen. It is indicated in the treatment of adult patients with KRAS G12C mutant non-small cell lung cancer. This mutation makes up >50% of all KRAS mutations. Mutant KRAS discovered in 1982 but was not considered a druggable target until the mid-2010s. It is the first experimental KRAS inhibitor. The drug MRTX849 is also currently being developed and has the same target. Sotorasib was granted FDA approval on May 28, 2021, followed by the European Commission's approval on January 10, 2022.
Indication
Sotorasib is indicated in the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have received at least one prior systemic therapy.
Associated Conditions
- Locally Advanced Non-Small Cell Lung Cancer
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/04 | Phase 1 | Recruiting | |||
2025/02/03 | Phase 1 | Recruiting | |||
2024/09/03 | Phase 2 | Recruiting | |||
2024/08/01 | N/A | Recruiting | |||
2024/07/11 | Phase 3 | Recruiting | |||
2024/03/27 | Phase 2 | Recruiting | |||
2024/03/27 | Phase 1 | Recruiting | |||
2024/03/18 | Phase 4 | Completed | |||
2024/02/12 | Phase 3 | Recruiting | |||
2024/02/08 | Phase 1 | Recruiting | City of Hope Medical Center |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
LUMAKRAS | Amgen Inc | ORAL | 320 mg in 1 1 | 2023/04/27 | 55513-504 |
LUMAKRAS | Amgen Inc | ORAL | 120 mg in 1 1 | 2023/04/27 | 55513-488 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|---|---|---|---|---|---|---|---|
Lumykras | EMEA/H/C/005522 | Amgen Europe BV,Minervum 7061,4817ZK Breda,The Netherlands | the netherlands | Conditional | Authorised | 2022/01/06 | 2021/11/11 | 6 |
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
|---|---|---|---|---|---|---|
LUMAKRAS FILM-COATED TABLET 120MG | Patheon Inc. | TABLET, FILM COATED | 120mg | 2022/06/28 | SIN16522P | Yes |
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|
No China products found
No China products found for this drug
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
LUMAKRAS sotorasib 120 mg film-coated tablet blister pack | 353210 | Amgen Australia Pty Ltd | Active | 2022/03/30 | sotorasib |