Lisocabtagene maraleucel

Bristol Myers Squibb's Breyanzi has scored an FDA approval in its fifth cancer type, marginal zone lymphoma. With FDA approval to treat marginal zone lymphoma (MZL), Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for five different types of blood cancer.The U.S. regulator has endorsed the one-time infused CD19-directed treatment for adult patients with relapsed or refractory MZL who have received at least two lines of prior therapy.Breyanzi, which broke through in 2021 with a nod for large B-cell lymphoma, has also been blessed by the U.S. regulator to treat mantle cell lymphoma (MCL) and follicular lymphoma (FL), as well as chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL).The latest endorsement gives BMS a leg-up on Gilead’s CD19-directed duo of Yescarta and Tecartus, which have been approved for a combined four blood cancer indications, with the latter CAR-T owning a unique nod in B-cell acute lymphoblastic leukemia.As for MZL, which accounts for roughly 7% of all non-Hodgkin's lymphoma cases, the slow-growing disorder develops when white blood cells clump together in the lymph nodes or organs. Remission is often accomplished with initial therapy, but relapse is common and can occur often and over the span of several years. Some MZL cases can progress into large B-cell lymphoma, which is more aggressive.“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a release.Setting Breyanzi up for approval included results from the phase 2 Transcend FL trial, which enrolled 66 MZL patients and reported a 95% overall response rate, with 62% of participants achieving a complete response. Of the responders, 90% maintained their response through 24 months.With MZL, there is a “pressing need for new treatment options with durable outcomes,” according to study investigator M. Lia Palomba, M.D., a lymphoma and cell therapy specialist at the Memorial Sloan Kettering Cancer Center.Palomba characterized the approval as “a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.” In the MZL cohort of the study, any grade cytokine release syndrome (CRS) occurred in 76% of patients. Any grade nervous system disorders included headache (21%), tremor (21%), encephalopathy (21%), dizziness (16%), and aphasia (10%), BMS said.With Breyanzi, BMS is playing catch-up with Gilead, which scored its first CAR-T approval with Yescarta in 2017. The treatment became a blockbuster in 2022 and achieved sales of $1.6 billion last year, in addition to sales of $403 million for Tecartus, which reached the market in 2020. Gilead’s revenues from the two CAR-Ts are now in decline, however, with third-quarter sales down for Yescarta by 10% and for Tecartus by 15%. Their combined sales were $432 million for the period.Meanwhile, BMS reported revenues from Breyanzi were up 58% to $359 million in Q3. With sales of $907 million so far this year, Breyanzi is set to become a blockbuster for the first time.BMS gained Breyanzi with its $74 billion acquisition of Celgene in 2019. The deal came less than a year after Celgene gained the treatment with its $9 billion buyout of Juno Therapeutics.