Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been given at least one prior systemic therapy.
Sotorasib marks Amgen’s first BTD submission in China, and also the first under its collaboration with Chinese biotech company BeiGene.
David M. Reese – executive vice president of Research and Development at Amgen said: “Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib.
“This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation.”
The breakthrough therapy designation in China for sotorasib has been driven by the positive results of the CodeBreaK 100 phase 2 study in patients having advanced NSCLC whose cancer had progressed in spite of prior treatment with chemotherapy and/or immunotherapy.
In the mid-stage study, treatment with sotorasib showed durable anticancer activity with a positive benefit-risk profile, said Amgen.