Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS
(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).
The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.
In addition, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled.
The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.
Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris
Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs
Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4
Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959
U.S. Consumer Prices Increase In Line With Estimates In August
IEA Cuts Oil Demand Forecast; Canadian Markets Eye Recovery
Canadian Dollar Falls As Oil Prices Edge Lower
