European Commission Approves BMS’ Breyanzi for Large B-Cell Lymphoma

Bristol-Myers Squibb (BMS) has received European Commission approval for its chimeric antigen receptor (CAR) T-cell drug Breyanzi (lisocabtagene maraleucel) to treat several forms of lymphoma — cancer of the lymph system — in adult patients.

The drug is approved for diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B for patients who have relapsed within 12 months of completion or are resistant to first-line chemoimmunotherapy.

In DLBCL, the most common form of non-Hodgkin lymphoma, up to 40 percent of patients have disease that is refractory to or relapses following initial therapy, the company said.

The approval is based on the results of a Phase 3 trial in which Breyanzi demonstrated significant improvement in event-free survival of 10.1 months compared to standard therapy of 2.23 months and complete response of 73.9 percent compared to 43.5 percent on standard therapy.

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