Bristol Myers Squibb’s Breyanzi Receives FDA Approval.
On Friday, February 5th, 2021, the U.S. Food and Drug Administration published a press release announcing the approval of CD19-targeting CAR T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel). Breyanzi is approved to treat adult patients with relapsed or refractory large B-cell lymphoma that has not responded following “two or more lines of systemic therapy, 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.” Breyanzi is manufactured by Juno Therapeutics, a Bristol Myers Squibb Company.
According to BMS Chief Medical Officer, Samit Hirawat, M.D., “Breyanzi, a CAR T cell therapy, will have an important role in clinical practice, offering people living with relapsed or refractory large B-cell lymphoma the chance for sustained response with an individualized treatment experience.” “Today’s FDA approval reflects our deep commitment to advancing cell therapy research, developing innovative treatments and supporting patients at every step of their treatment journey.”
Breyanzi is slated to be manufactured at Bristol Myers Squibb’s state-of-the-art cell therapy manufacturing facility in Bothell, Washington, a scant three miles away from BioLife Solutions’ cGMP-certified biopreservation media manufacturing suites. Notably, BioLife Solutions’ CryoStor CS10 is used for cryopreservation as disclosed in the Breyanzi Prescribing Information brochure.
BioLife Solutions is proud to serve as the critical cryopreservation media manufacturer and supplier of CryoStor, chosen for the cryopreservation of FDA-approved anti-CD19 CAR T cell therapies Yescarta, Tecartus, and now, Breyanzi.
BioLife Solutions Products and Services
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