Bristol Myers Gets Positive CHMP Opinion For Breyanzi in Lymphoma

By Michael Dabaie

Bristol Myers Squibb Co. said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Breyanzi for adults with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

The European Commission will now review the CHMP recommendation. The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all European Union member states and Iceland, Norway and Liechtenstein.

The CHMP adopted a positive opinion based on results from Transcend NHL 001, a trial of patients with relapsed or refractory LBCL after at least two prior therapies, and additional data from the Transcend World study, the company said.

The studies evaluated patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease, and patients who received Breyanzi in the inpatient and outpatient setting.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

01-28-22 0738ET