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The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
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Zacks Investment Research on MSNWill The Decline in Legacy Drugs Pull Down BMY's Top Line?Bristol Myers’ BMY legacy portfolio comprises Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane. Revenues for the Legacy ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.
Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...
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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.
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...
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 ...
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 ...
Breyanzi and its Previous Approvals. Breyanzi is a CD19-directed CAR T cell therapy that includes a 4-1BB costimulatory domain, which helps enhance the expansion and persistence of the CAR T cells in ...
“Breyanzi has opened the possibility of a complete and lasting response for the most threatened population of LBCL – those patients whose lymphoma doesn’t go away completely after first-line ...
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