Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)
Shots:
- The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT
- The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients
- The study showed that Lumakras (960mg) + Vectibix (n=53) achieved improved PFS, mPFS (1EP; 5.6 vs 2mos.) & ORR (2EPs; 26% vs 0%), plus OS (2EPs) was insignificant, with mOS not reached vs 10.3 mos. The PFS of Lumakras (240mg) + Vectibix (n=53) was not clinically meaningful
Ref: Amgen | Image: Amgen
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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.