A KRAS drug is likely coming — fast — as the FDA points Amgen’s frontrunner to a looming finish line
Amgen got the oncology world excited with a first look at the potential for a KRAS drug to end a decades-long roadblock in R&D. And while the field has cooled somewhat through 2020, the pharma giant now has a formal commitment from the FDA to hurry it along as researchers prep the finishing touches to their new drug application.
Amgen reported Tuesday morning that the agency has proffered its breakthrough therapy designation for its KRAS G12C inhibitor sotorasib for advanced cases of non-small cell lung cancer, with plans to file for an approval before the end of the month. Helping them along even more, their drug has been accepted into the FDA’s Real-Time Oncology Review pilot program — a not-so-subtle endorsement of Amgen’s trial design that offers a road map for developers to push through to a marketing decision.
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