Incyte (INCY) said Sunday that the Food and Drug Administration has granted Breakthrough Therapy designation to its experimental treatment for a rare blood cancer. The biotech also released updated Phase 1 trial results for the drug.
Incyte's INCA033989 is an experimental monoclonal antibody to treat a specific form of essential thrombocythemia, a rare blood cancer that causes dangerously high platelet counts. The patients carry a Type 1 mutation in the CALR gene and can no longer tolerate or don't respond to standard treatments to suppress blood cell production.
The FDA's decision followed initial Phase 1 results from earlier this year that showed sustained platelet reductions.
Also Sunday, Incyte presented updated Phase 1 results at the 2025 American Society of Hematology annual meeting. That included further safety and efficacy data for essential thrombocythemia as well as new data for patients with myelofibrosis.
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