US FDA reviewers raise concerns on Amgen's sNDA for Lumakras

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) is set to review data supporting US biotech giant Amgen’s (Nasdaq: AMGN) supplemental New Drug Application (sNDA) for the full approval of Lumakras (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) at a meeting on October 5, 2023.

Lumakras, which generated sales of $285 million in 2022,  was first approved by the FDA in 2021 under the accelerated program for adult patients NSCLC.

Ahead of the meeting, FDA staff reviewers in their briefing documents raised concerns over the adequacy of the company's Phase III trial of Lumakras to support claims of effectiveness of the lung cancer drug. Amgen shares closed down 2% at $261.01 yesterday.