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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Breyanzi (lisocabtagene maraleucel) (CD19-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Title:
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Published date:
03/14/2024
Excerpt:
...the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
Title:
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel)for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Published date:
11/09/2023
Excerpt:
Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received a prior Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i)...The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024. Priority Review designation underscores the high unmet need and the significant advancement Breyanzi may offer this patient population for which there is no standard of care and limited treatment options.
