Breyanzi represents a differentiated CAR T cell therapy with demonstrated rapid and durable complete responses and a manageable safety profile Approval of Breyanzi is based on results from TRANSCEND
The FDA has accepted Bristol Myers Squibb's application for Breyanzi as a second-line treatment for relapsed or refractory large B-cell lymphoma. The regulator has assigned it priority review with a decision deadline of June 24.
BMY Reports Positive Results From Phase 3 Breyanzi Trial In Second-line Relapsed Or Refractory LBCL
NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) announced Thursday positive topline results from Phase 3 TRANSFORM trial evaluating Breyanzi (lisocabtagene maraleucel) versus chemotherapy followed by stem cell transplant in second-line relapsed or refractory large B-cell lymphoma or LBCL.
The trial 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. Overall survival data were immature at the time of this interim analysis, the company noted.
TRANSFORM global, randomized, multicenter Phase 3 study evaluates Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory LBCL compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant, which is curr
May 3, 2021 9:50am
Bristol Myers Squibb plans to pilot a virtual reality training program at its upcoming cell therapy plant in Massachusetts and that s just the tip of the high-tech iceberg.
Even as more cell therapies push past the finish line, questions about how to make the personalized medicines swiftly and dependably persist. For Bristol Myers Squibb, which is standing up two new cell factories, automation and high-tech training will form twin jewels in its production crown, an exec said.
Making cell therapies such as BMS recently approved CAR-T meds Breyanzi and Abecma is a highly personal process. There s apheresis, when T cells are gathered straight from the patient, plus the process of re-engineering the cells and getting them quickly back to patients.
Apr 22, 2021 7:00am
Bristol Myers Squibb s upcoming cell therapy plant in the Netherlands should help slash turnaround times for patients receiving its CAR-T therapies there. (Bristol Myers Squibb)
Right on the heels of not one, but two CAR-T approvals in the U.S., Bristol Myers Squibb is bolstering its commercial cell therapy ambitions on the other side of the Atlantic.
The company on Thursday pegged Leiden, Netherlands, as the home of its first cell therapy factory in Europe and its fifth worldwide. With planning for site design and development underway, BMS expects construction to kick off later this year.
BMS swift cell therapy scale-up, which also includes a commercial plant-to-be in Massachusetts, follows FDA green lights for the company s closely-watched CAR-T therapies Breyanzi and Abecma in February and March, respectively. Neither med has won an approval yet in Europe.