On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January 17, 2025.
This application is supported by data from the Phase III CodeBreaK 300 study (NCT05198934). Data presented at the ASCO 2024 conference indicated a trend toward improved overall survival (OS) for mCRC patients treated with sotorasib and panitumumab compared to those receiving investigator-selected therapies, including trifluridine/tipiracil or regorafenib. The median OS for the sotorasib and panitumumab cohort has not yet been reached, while the median OS for the comparator group was 10.3 months, yielding a hazard ratio of 0.70.
Earlier this year, on June 21, Bristol Myers Squibb’s KRAS inhibitor Krazati (adagrasib) received FDA approval for use in combination with cetuximab for second-line treatment of adult patients with locally advanced or metastatic colorectal cancer harboring KRAS G12C mutations.- Flcube.com
