FDA Grants Sotorasib Priority Review Designation for Advanced, Metastatic NSCLC

Amgen announced 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.

Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest global clinical program exploring 10 combinations with clinical sites spanning five continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 700 patients studied across 13 tumor types.

NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis. KRAS G12C is one of the most common driver mutations in NSCLC and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC. In the U.S., approximately 25,000 new patients are diagnosed with KRAS G12C-mutated NSCLC each year.