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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Follicular Lymphoma |
| Drug: | Breyanzi (lisocabtagene maraleucel) (CD19-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Title:
Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma
Published date:
05/15/2024
Excerpt:
Bristol Myers Squibb...announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for 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 follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
Title:
Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
Published date:
05/03/2023
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy....The approval is based on results from the pivotal Phase 3 TRANSFORM trial in which Breyanzi demonstrated statistically significant and clinically meaningful improvements in the study’s primary endpoint of event-free survival (EFS), and key secondary endpoints of complete responses (CR) and progression-free survival...
Title:
Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma
Published date:
04/05/2022
Excerpt:
Bristol Myers Squibb...announced that the European Commission (EC) has granted Marketing Authorization for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The Marketing Authorization approves Breyanzi for use in all European Union (EU) member states.
Title:
Japan’s Ministry of Health, Labour and Welfare Approves Breyanzi, a New CAR T Cell Therapy
Published date:
03/25/2021
Excerpt:
Bristol Myers Squibb K.K. this week announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma.
Source:
Published date:
04/30/2024
Excerpt:
Subsequent systemic therapy options include second-line therapy regimens...Lisocabtagene maraleucel (CD19-directed)
