Bristol Myers Squibb gets positive EMA Committee opinion for Breyanzi for Relapsed or Refractory Large B-cell Lymphoma after one prior therapy

“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “We look forward to continuing to work with the European Medicines Agency with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people.”

The CHMP adopted a positive opinion based on results from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant (HSCT).

In the European Union (EU), the European Commission delivers its final decision within approximately two months following receipt of the CHMP opinion. The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.

Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, 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, or relapsed or refractory disease after two or more lines of systemic therapy. Breyanzi is also approved in Japan for the second-line treatment of relapsed or refractory LBCL, and in Japan, Europe, Switzerland and Canada for relapsed or refractory LBCL after two or more lines of systemic therapy.