Thumbs down from FDA AdCom on Amgen's Lumakras

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) yesterday found that data from a late-stage trial was not reliable enough to support traditional approval of US biotech giant Amgen's (Nasdaq: AMGN ) Lumakras (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) for patients with a type of advanced lung cancer.

The committee was asked to vote on: Can the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), be reliably interpreted in CodeBreaK 200? The AdCom vote was 10 against and two for.

The drug was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data a condition for gaining traditional approval. The AdCom vote was 10 against and two for traditional approval.