FDA grants Bristol Myers Squibb OK for 2 new indications for Breyanzi

Bristol Myers Squibb has received permission from the Food and Drug Administration for Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma 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, who have:

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.

With these two new indications, Breyanzi now has the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

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“As part of our commitment to developing innovative cancer treatments for patients with critical unmet need, Breyanzi offers a potentially curative option for more patients,” said Ester Banque, senior vice president and general manager of U.S. hematology at Bristol Myers Squibb. “Based on the demonstrated clinical benefit, this approval of Breyanzi underscores the significant advances we are making to deliver on the promise of cell therapy.”

LBCL is a difficult to treat and aggressive blood cancer, and up to 40% of patients have disease that is refractory to or relapses after initial therapy. Historically, the only potential cure for these patients is the current standard of care consisting of intensive hospital-based salvage immunochemotherapy followed by high-dose chemotherapy and HSCT in those whose disease responds to the salvage therapy.

However, half of patients are not considered candidates for a stem cell transplant due to age and/or comorbidities, and only an estimated 25% of those who are candidates are able to receive a stem cell transplant and experience long-term clinical benefit. For patients who are not considered candidates for stem cell transplant, treatment options are limited. If left untreated, relapsed or refractory LBCL has a life expectancy of just three to four months.

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“Breyanzi represents a remarkable advance over a nearly 30-year standard of care, providing significantly improved efficacy with a well established safety profile,” said Manali Kamdar, lead investigator of the Transform study and associate professor, clinical director of lymphoma services, division of hematology, hematologic malignancies and stem cell transplantation at the University of Colorado Cancer Center.

“This important milestone reinforces the benefit of offering a CAR T-cell therapy option to patients earlier in their treatment journey, and it’s critical that we begin the work to implement this therapy into standard practice as a second-line treatment in order to help improve outcomes for more patients,” Kamdar said.

“Patients with large B-cell lymphoma whose disease does not respond to or relapses after first-line therapy often face lengthy and intensive cycles of chemotherapy with the goal of proceeding to stem cell transplant,” said Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society. “As one of the earliest supporters of CAR T since the 1990s, LLS is excited to see the FDA approval of a CD19 CAR T-cell therapy that has moved from later lines of therapy to a second-line option, which offers patients with relapsed or refractory large B-cell lymphoma the potential for long-term remission and the hope of a cure.”