Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

December 17, 2020 Auto Bot Advanced, Amgen, Metastatic, NDA, NSCLC, regulatory, reports, Sotorasib, Submission, Us FDA 0

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Axios

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