Amgen to discuss application for full approval for Lumakras to treat KRAS G12C positive NSCLC at FDA Advisory Committee meeting
Amgen announced the FDA Oncologic Drugs Advisory Committee (ODAC) will review data supporting the 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/Lumykras is approved in several markets outside the United States including Europe, South America, Asia and the European Union. To date, over 6,500 patients around the world have received Lumakras/Lumykras through the clinical development program and commercial use. 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.
LUMAKRAS received accelerated approval from the FDA on May 28, 2021. The sNDA for full approval of Lumakras was accepted by the FDA for standard review and a Prescription Drug User Fee Act (PDUFA) target action date of December. 24, 2023, has been set.
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