Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

December 9, 2020 Auto Bot Amgen, Breakthrough Therapy Designation, receives, regulatory, Sotorasib, US FDA’s 0

Shots:

  • The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy
  • The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen has several P-Ib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment
  • Sotorasib has also accepted into FDA’s Real-Time Oncology Review Pilot Program. Additionally, the company plans to submit the NDA to the US FDA by the end of 2020

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

The post Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation first appeared on PharmaShots.