“FDA has accepted the supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel)” bms.com ↗
Fileddiffuse large B-cell lymphoma1 milestone
Filed
EU (EMA)
Breyanzi
diffuse large B-cell lymphoma
2022-06-20
“validated its type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma” bms.com ↗
Filedlarge B-cell lymphoma3 milestones
Filed
Japan (PMDA)
Breyanzi
large B-cell lymphoma
2022-03-25
“today announced that the Ministry of Health, Labour and Welfare (MHLW) has accepted the supplemental New Drug Application for Breyanzi (lisocabtagene maraleucel)” bms.com ↗
Filed
US (FDA)
Breyanzi
large B-cell lymphoma
2022-02-17
“FDA has accepted its supplemental Biologics License Application (sBLA) for Breyanzi” bms.com ↗
Filed
US (FDA)
—
large B-cell lymphoma
2020-02-13
“FDA has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel)” bms.com ↗
alongside long-term results for Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, from the Phase 3 TRANSFORM and Phase 2 TRANSCEND FL trials.
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to 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 mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response, with 62.1% achieving complete response and 88.6% maintaining a response at 24 months
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to 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) after two or more lines of systemic therapy.
Validation of the application confirms the submission is complete and allows the scientific review to begin under the EMA’s centralized review procedure.
Bristol Myers Squibb (NYSE: BMY) today announced three regulatory acceptances from the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi ® (lisocabtagene maraleucel).
First presentation of results from primary analysis of Phase 2 TRANSCEND FL study evaluating second-line treatment with Breyanzi ® (lisocabtagene maraleucel; liso-cel) in relapsed or refractory follicular lymphoma demonstrate its potential best-in-class and best-in-disease profile
In TRANSCEND FL, 97% of patients with relapsed or refractory follicular lymphoma treated with Breyanzi achieved a response, with 94% achieving a complete response, and 81.9% of responders in ongoing response at 12 months
At a median follow-up of 21.1 months, results show that Breyanzi delivered statistically significant complete response (CR) rates, the study’s primary endpoint, in 18.4% of patients in the primary efficacy analysis set (95% CI: 8.8-32; p=0.0006).
First presentation of results from primary analysis of TRANSCEND CLL 004 demonstrates benefit of Breyanzi (lisocabtagene maraleucel) in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
Results showed both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and clinically meaningful responses in relapsed or refractory FL and MCL.
The results from the PILOT study, including the patient-reported outcomes, show that treatment with liso-cel as a second-line therapy offers durable responses with improved quality of life for patients who historically have had poor prognosis.
First disclosure of data from the PILOT study of Breyanzi (liso-cel), in patients with relapsed or refractory large B-cell lymphoma after one line of therapy who were not intended for transplant, show substantial durable responses.
The CHMP adopted a positive opinion based on results from TRANSCEND NHL 001, the largest pivotal trial of patients with R/R LBCL after at least two prior therapies, and additional data from the TRANSCEND WORLD study.
Phase 3 TRANSFORM study shows Breyanzi significantly improved event-free survival (EFS) vs. chemotherapy plus autologous stem cell transplant, with a 65% reduction in risk of EFS events in first disclosure of results presented at ASH 2021
Study met primary and key secondary endpoints, demonstrating a highly statistically significant improvement in event-free survival, complete response rate and progression-free survival compared to standard of care
At a median follow-up of 11 months, the overall response rate (ORR) for patients receiving liso-cel was 81.5% (18/22, 95% CI: 59.7 – 94.8) with 45.5% (10/22) of patients achieving a complete response (CR).
Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses
Every value below carries the sentence it was read from.
28 sources stand behind the page.
Field
Value
Cited text
Known as
lisocabtagene maraleucel
“The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗18
“Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .” NCT07052305 ↗
“The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel.” NCT05934448 ↗
“Lisocabtagene maraleucel is a CAR-T cell therapy made from an individual's own immune (T) cells.” NCT07711483 ↗
“The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗
Known as
Breyanzi
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT03642626 ↗
Known as
JCAR017
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT03331198 ↗6
“The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene...” NCT07711483 ↗3
“The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗
“zanubrutinib and lisocabtagene maraleucel (liso-cel) work together” NCT05873712 ↗