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Bristol-Myers Squibb Says Application to Expand Breyanzi Indication Validated in EU
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Bristol-Myers Squibb Says Application to Expand Breyanzi Indication Validated in EU
Aug 19, 2024 5:22 AM

07:59 AM EDT, 08/19/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Monday that its application to expand the indication for its CAR T cell therapy Breyanzi has been validated by the European Medicines Agency, paving the way for its review.

The company said it submitted a Type II variation application for Breyanzi, or lisocabtagene maraleucel, to include treatment of adults with relapsed or refractory follicular lymphoma who have undergone at least two systemic therapies.

Breyanzi is already approved in the European Union for adults with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B, according to the company.

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