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...

Bristol-Myers Squibb K.K. today announced that it has received approval in Japan for Breyanzi (generic name: lisocabtagene maraleucel; liso-cel), a CD19-targeting chimeric antigen receptor (CAR) T cell therapy (gene-modified autologous therapy), allowing its use in the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL), regardless of whether autologous hematopoietic stem-cell transplantation is intended.

Bristol Myers Squibb... that the U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B...Results from the TRANSFORM study showed, Breyanzi (n=92)more than quadrupled median EFS compared to standard therapy (n=92) (10.1 months vs. 2.3 months [HR: 0.34; 95% CI (0.22-0.52) p<0.0001]). The majority of patients achieved a CR with Breyanzi compared to less than half with standard therapy (66% [95% CI: 56% - 76%] vs. 39% [95% CI: 29% - 50%]; p<0.0001), with median duration of CR not reached in the Breyanzi arm (95% CI: 7.9-NR). Results also showed Breyanzi more than doubled PFS versus standard therapy (median PFS: 14.8 months vs. 5.7 months [HR: 0.41; 95% CI: 0.25-0.66; p=0.0001]).

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.

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.

...the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

The European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies....The median progression-free survival (PFS) was 6.8 months (95% CI, 3.3-14.1), with just under half of the patients, or 44%, remaining free of disease progression. The median OS reported with liso-cel was 21.1 months (95% CI, 13.3-not reached), and more than half of patients (58%) were still alive at 1 year, including 86% of those who achieved CRs.

Lisocabtagene maraleucel is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma...Lisocabtagene maraleucel was added as a category 2A recommendation.

Bristol Myers Squibb...announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) 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 CHMP adopted a positive opinion based on results from the pivotal Phase 3 TRANSFORM study

Bristol Myers Squibb...today announced positive topline results from TRANSFORM, a global, randomized, multicenter Phase 3 study evaluating Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)...the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care.