Enliven Therapeutics Reaches Realignment With FDA on Final Design of Relcobatinib's Phase 3 Trial
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Enliven Therapeutics (ELVN) is on track to start its phase 3 trial of relcobatinib in patients with previously treated chronic myeloid leukemia before the end of 2026, the company said Wednesday.
The move comes after the company aligned with the US Food and Drug Administration on the trial's final design.
The trial is designed to directly compare relcobatinib with second-generation tyrosine kinase inhibitors and is expected to enroll 450 adults with chronic myeloid leukemia.
The primary endpoint is major molecular response at week 24, the company said.
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