Bristol-Myers Squibb (BMY) said Friday that Breyanzi has received approval from the European Commission for the treatment of adult patients with relapsed or refractory follicular lymphoma.
The additional approval is based on results of a phase 2 study, where Breyanzi showed a high overall response rate of 97.1% and complete response rate of 94.2%, the respective primary and key secondary endpoints of the study, the company said.
The company added that safety results were in line with the safety profile of Breyanzi in clinical trials and approved indications.
Breyanzi's approved indications in the EU include the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, according to Bristol-Myers Squibb.
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