Amgen (AMGN) Announces FDA Grants Sotorasib Priority Review Designation For Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic NSCLC

February 16, 2021 4:00 PM EST

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Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.

The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.

The New Drug Application (NDA) is based on the Phase 2 results from the CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. Full results from the study were recently 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 sotorasib NDA on Dec. 16, 2020. The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the EU in Dec. 2020. Additionally, Amgen submitted MAAs for sotorasib in Australia, Brazil, Canada and the United Kingdom in Jan. 2021 to participate in the FDA's Project Orbis initiative. Sotorasib has achieved Breakthrough Therapy Designation in the U.S. and China.

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