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FDA Grants Priority Review to Sotorasib to Treat Patients With KRAS G12C–Mutated NSCLC

The FDA granted priority review to sotorasib to treat patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), according to an Amgen press release.

The designation for sotorasib is intended for patients with this disease following at least 1 prior systemic therapy. The drug has a Prescription Drug User Fee Action (PDUFA) date of August 16, 2021, which is 4 months earlier than the FDA’s typical review cycle.

The new drug application (NDA) comes in response to data from the CodeBreaK 100 clinical trial (NCT03600883) that was presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).

Amgen submitted the NDA for sotorasib on December 16, 2020, and the FDA is reviewing the application via Real-Time Oncology Review (RTOR), which is a pilot program…

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