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Home » FDA Grants Priority Review for Liso-Cel in B-cell Lymphoma
FDA Grants Priority Review for Liso-Cel in B-cell Lymphoma
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Bristol-Myers Squibb’ subsidiary Juno Therapeutics received priority review from the FDA for lisocabtagene maraleucel (liso-cel) to treat adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The BLA is based on results from a clinical trial in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.
Liso-cel was previously granted breakthrough therapy and regenerative medicine advanced therapy designations by the FDA.
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