BMS Reports the US FDA’s Acceptance of sNDA for the Combination of Krazati & Cetuximab with Priority Review to Treat Colorectal Cancer (CRC)
Shots:
- The US FDA has accepted and granted priority review to the sNDA for Krazati + cetuximab for previously treated KRASG12C-mutated locally advanced/metastatic CRC with the decision expected on Jun 21, 2024
- The sNDA was based on the P-I/II (KRYSTAL-1) study assessing the safety and efficacy of Krazati for the treatment of KRASG12C mutated advanced solid tumors. ORR is the 1EP for the P-II part while DoR, PFS, OS and safety are the 2EPs
- The results demonstrated Krazati’s favorable clinical efficacy with a tolerable and consistent safety profile when compared to previous studies
Ref: BMS | Image: BMS
Related Posts:- Mirati Therapeutics’ Krazati (adagrasib) Receives EC’s Approval for Advanced Non-Small Cell Lung Cancer (NSCLC)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
