The approval is based on data from a Phase 3 trial, which involved 405 patients, according to an Oct. 29 news release from the agency. The study showed a major molecular response rate of 68% at 48 weeks for asciminib compared to 49% for standard tyrosine kinase inhibitors.
Common adverse reactions included musculoskeletal pain, rash and fatigue, the release said. The approval utilized the FDA’s Real-Time Oncology pilot program, streamlining the review process.
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