Amgen submits NDA for Sotorasib in non-small cell lung cancer

 

• Amgen (NASDAQ:AMGN)  announced the submission of a New Drug Application with the FDA for sotorasib in the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
• Backed by positive Phase 2 results from Amgen’s CodeBreaK 100 clinical study, the NDA submission for sotorasib, the first KRASG12C inhibitor to enter the clinic, is reviewed under FDA’s Real-Time Oncology Review pilot program to accelerate the review process.
• Involving 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline, the Phase 2 study was the first-in-human, open-label multicenter study. It was part of CodeBreaK, the KRAS G12C clinical development program of Amgen, which has enrolled than 600 patients across 13 tumor types.
• A global Phase 3 randomized active-controlled study is currently recruiting patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) to evaluate Sotorasib against docetaxel.
• In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
• "Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation,” he further added.
• https://seekingalpha.com/news/3645142-amgen-submits-nda-for-sotorasib-in-non-small-cell-lung-cancer