Amgen sends first KRAS drug to the FDA, approval could follow swiftly
It only took a decade or 3, but KRAS will finally have its day in court.
Amgen announced late Wednesday that they had submitted their KRAS inhibitor sotorasib to the FDA for approval in patients with metastatic non-small cell lung cancer and a KRAS G12C mutation. An approval could come swiftly, as the agency has given the molecule breakthrough designation and included it in their rare “real-time oncology review” program — the same program that, in 2018, allowed the FDA to OK a Novartis drug in less than a month.
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