KRAS G12C lung cancer targeted therapy full FDA approval conversion with KRAS inhibitor treatment
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Amgen Receives Full FDA Approval for Lumakras in KRAS G12C-Mutated Lung Cancer

Amgen announces FDA conversion to full approval for sotorasib (Lumakras) for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC.

Amgen today announced that the FDA has converted the accelerated approval of Lumakras (sotorasib) to full approval for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy. The conversion was based on overall survival data from the Phase 3 CodeBreaK 200 trial demonstrating a statistically significant improvement in OS. This full approval reinforces Lumakras as a standard treatment option for KRAS G12C-mutated NSCLC.

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