Amgen says FDA AdCom to discuss Lumakras sNDA

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting 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, the biotech major has announced.

Lumakras was first approved by the FDA in 2021 under the accelerated program for adult patients NSCLC whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. Apart from the USA, Lumakras is approved in several markets including Europe, South America, Asia. To date, over 6,500 patients around the world have received Lumakras, also marketed under the Lumykras name, through the clinical development program and commercial use.

Amgen noted that Lumakras has demonstrated a favorable benefit/risk profile in multiple studies in non-small lung cancer and other tumor types such as colo-rectal cancer. Amgen is progressing the largest and broadest global KRASG12C inhibitor development program exploring multiple combination regimens, with clinical trial sites spanning five continents.