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FDA Grants Priority Review to Liso-Cel for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of lisocabtagene maraleucel to include patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor. ....

Bristol Myers Squibb , Anne Kerber , Late Clinical Development , International Workshop On Chronic Lymphocytic Leukemia , Prescription Drug User Fee Act , Cell Therapy , International Workshop , Chronic Lymphocytic Leukemia , Priority Review , Lisocabtagene Maraleucel , Liso Cel , Cart Cell Therapy , Small Lymphocytic Lymphoma , Blood Cancer , Non Hodgkin Lymphoma , Transcend Cll 004 ,

Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy

The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
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Anne Kerber , Cell Therapy Development At Bristol Myers Squibb , European Commission , Cell Therapy Development , Bristol Myers Squibb , Cart Cell Therapy , Global Oncology , Isocabtagene Maraleuce , Liso Cel , Diffuse Largeb Cell Lymphoma ,