Lumakras FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 18, 2025.
FDA Approved: Yes (First approved May 28, 2021)
Brand name: Lumakras
Generic name: sotorasib
Dosage form: Tablets
Company: Amgen Inc.
Treatment for: Non Small Cell Lung Cancer, Colorectal Cancer
Lumakras (sotorasib) is a KRAS G12C inhibitor used for the treatment of KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.
- Lumakras is indicated for:
- KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
• As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)
- In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Development timeline for Lumakras
Further information
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