Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation
Shots:
- The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
- The study provided durable anticancer activity with a positive benefit-risk profile
- The US FDA has reviewed the NDA under RTOR pilot program- which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible
Ref: PRNewswire | Image: Axios
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