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

 ­ Ref: PRNewswire | Image: BioSpace