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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.
With these results, Breyanzi has now demonstrated clinically meaningful benefit across the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy, underscoring the... | May 1, 2023
Lisocabtagene maraleucel elicited statistically significant and clinically meaningful responses in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma, meeting the primary end point of the phase 2 TRANSCEND FL and phase 1 TRANSCEND NHL 001 trials, respectively.
U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023 European Medicines Agency has... | April 17, 2023
U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023European Medicines Agency has validated Bristol Myers Squibb’s Type II variation application for AbecmaBristol Myers Squibb’s supplemental New Drug Applicatio...