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Bristol-Myers: FDA To Review BLA For Liso-cel - Quick Facts

Bristol-Myers Squibb Company (BMY) announced the U.S. FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel, or liso-cel, for adult patients with Relapsed or Refractory Large B-Cell Lymphoma. Liso-cel is an investigational compound that is not approved for use in any country.

Liso-cel was previously granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations by the FDA for R/R aggressive large B-cell non-Hodgkin lymphoma and Priority Medicines (PRIME) scheme by the European Medicines Agency for R/R diffuse large B-cell lymphoma.

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