Lumakras FDA Approval History
Last updated by Judith Stewart, BPharm on June 2, 2021.
Lumakras (sotorasib) is a KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following 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).
Development timeline for Lumakras
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