FDA Grants Priority Review for Liso-Cel in B-cell Lymphoma

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.