FDA grants breakthrough therapy status to sotorasib for lung cancer subset
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The FDA granted breakthrough therapy designation to sotorasib for the treatment of certain patients with non-small cell lung cancer, according to the agent’s manufacturer.
The designation applies to use of the agent by patients with locally advanced or metastatic NSCLC who have KRAS G12C mutations and received at least one prior systemic therapy.
Sotorasib (AMG 510, Amgen) also will be evaluated under the FDA’s Real-Time Oncology Review Pilot Program, designed to accelerate the delivery of effective and safe cancer treatments to patients.
Approximately 25,000 people in the United States are diagnosed with KRAS G12C-mutated NSCLC each year. This represents about 13% of new NSCLC adenocarcinoma cases.
Treatment options are limited for patients who failed first-line treatment. Fewer than 20% of patients respond to second-line treatment, and median PFS is approximately 4 months.
The FDA based the breakthrough therapy designation on results of the phase 1/phase 2 CodeBreaK 100 study, which included patients with advanced solid tumors and KRAS G12C mutations whose disease progressed after prior chemotherapy and/or immunotherapy. Results showed sotorasib demonstrated durable anticancer activity and a positive risk-benefit profile for patients with NSCLC, according to an Amgen-issued press release.
Recruitment is underway for a randomized phase 3 trial that will compare sotorasib with docetaxel for patients with KRAS G12C-mutated NSCLC.
“Breakthrough therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers,” David M. Reese, MD, executive vice president of research and development for Amgen, said in the release. “We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it.”
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