Press Release from Bristol Myers Squibb, a member of Bio Nebraska
PRINCETON, N.J.–Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved 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 (R/R) large B-cell lymphoma (LBCL) after 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 not indicated for the treatment of patients with primary central nervous system lymphoma.1 Breyanzi is a CD19-directed CAR T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4‑1BB signaling enhances the expansion and persistence of Breyanzi. Breyanzi offers a potentially definitive treatment. A single dose of Breyanzi contains 50 to 110 x 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components). Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS) and Neurologic Toxicities (NT).
“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,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Today’s FDA approvalreflects our deep commitment to advancing cell therapy research, developing innovative treatments and supporting patients at every step of their treatment journey.”
Bristol Myers Squibb plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facility in Bothell, Washington. Breyanzi offers a 24-day target turnaround time, and inpatient or outpatient administration options. To help support broad patient access, Bristol Myers Squibb plans to launch Breyanzi across an expansive network of treatment centers. Treatment centers will be Risk Evaluation and Mitigation Strategy (REMS) certified to support the appropriate use of Breyanzi, which is available only through the Breyanzi REMS program. Healthcare facilities, including hospitals and associated outpatient clinics, must enroll and comply with REMS requirements and be trained on the management of CRS and NT. Bristol Myers Squibb is also supporting the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, patient and caregiver support, and outpatient management resources to support patients. BMS will offer patients disposable wearable technology during the initial post-infusion monitoring period, which will help them track their temperature in real time through a smartphone when away from the treatment center.