FDA approves sotorasib (Lumakras) for treatment of patients with non-small cell lung cancer (NSCLC) whose tumours have KRAS G12C mutation

Sotorasib is approved for use in patients who have received ≥1 prior systemic therapy. FDA announced this is first approved targeted therapy for tumours with any KRAS mutation, which accounts for~25% of mutations in NSCLC, of which KRAS G12C mutations represent ~13% of mutations.

SPS commentary:

In a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, Sotorasib was associated with an objective response rate with of 36%.

A regulatory submission for this KRAS inhibitor was filed in EU in Dec 2020.


US Food and Drug Administration