Bristol Myers Squibb's Breyanzi Clinches European Green Light for Mantle Cell Lymphoma Treatment

Bristol Myers Squibb has secured European Commission approval to broaden its CAR T cell therapy Breyanzi’s therapeutic footprint, now clearing the way for its use against relapsed or refractory mantle cell lymphoma. The regulatory clearance extends across all European Union member states alongside Iceland, Norway, and Liechtenstein.

Clinical Evidence Drives Regulatory Decision

The approval hinges on compelling data from the MCL cohort within TRANSCEND NHL 001, a phase I single-arm study evaluating Breyanzi’s safety and antitumor efficacy in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Study participants had experienced disease progression despite prior exposure to at least two treatment regimens, including Bruton’s Tyrosine Kinase inhibitors.

Among heavily pretreated patients receiving Breyanzi in the third-line setting and beyond, the therapy demonstrated an 82.7% overall response rate with a robust 71.6% complete response rate. Perhaps most notably, at the 24-month follow-up mark, 41.2% of those who initially responded maintained their response, underscoring the durability of therapeutic benefit.

Understanding the Disease Context

Mantle cell lymphoma represents a particularly aggressive and rare subtype of non-Hodgkin lymphoma, arising within the mantle zone of lymph nodes. The condition predominantly affects elderly male patients, with median diagnosis age hovering around the mid-60s, creating substantial clinical challenges for managing this vulnerable population.

Expanded European Indication

Prior to this expansion, Breyanzi held European approval for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma. The U.S. market authorization encompasses these same indications plus chronic lymphocytic leukemia, small lymphocytic lymphoma, and now mantle cell lymphoma.

Commercial Momentum

Breyanzi’s market performance reflects growing clinical adoption. The therapy generated $966 million in global sales during the first nine months of 2025, marking a sharp acceleration from the $484 million recorded in the corresponding 2024 period—approximately doubling year-over-year.

BMY shares have fluctuated between $42.52 and $63.33 over the trailing 12 months, closing the previous session at $47.76, reflecting a 3.26% gain on the approval announcement.

Emma Charles, senior vice president for Bristol Myers Squibb’s Europe Region, emphasized the strategic importance: “Despite advances in frontline therapies, the majority of patients with this rare but aggressive lymphoma ultimately relapse or develop resistance, facing grim survival prospects. Breyanzi represents a meaningful therapeutic option filling this significant treatment void based on demonstrated clinical benefit.”