Amgen scores a first with FDA approval of Lumakras

The US Food and Drug Administration approved Lumakras (sotorasib: AMG 510) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy.

Developed by US biotech giant Amgen (Nasdaq: AMGN), this is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for around 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers, the FDA noted. Amgen’s shares closed up modest 1.1% at $237.94 on Friday.

The approval comes three months earlier than the previously-announced FDA action date of August 15. “The earlier approval, and the label, also improves Amgen’s competitive position compared to its closest rival, Mirati, by virtue of a widened time-to-market advantage,” commented SVB Leering analyst Geoffrey Porges.