News
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
Breyanzi demonstrated a 95.5% response rate among patients with relapsed/refractory marginal zone lymphoma, as well as a ...
3d
Pharmaceutical Technology on MSNFDA approves label updates for BMS’ CAR T cell therapiesBristol Myers Squibb has announced that the FDA has given approval to label updates for Breyanzi and Abecma to treat multiple myeloma.
The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.
Breyanzi (lisocabtagene maraleucel) is a type of treatment called a chimeric antigen receptor T-cell therapy (CAR T-cell) that uses your body's own immune system to treat your cancer. Breyanzi was ...
Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...
Bristol Myers Squibb today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi ® in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary ...
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...
Bristol Myers Squibb (NYSE:BMY) announced that the U.S. FDA has approved several label updates for its cancer therapies, ...
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