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FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma

On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed or refractory large B-cell lymphoma.”  Juno, a Bristol-Myers Squibb Company, was authorized to manufacture Breyanzi at its Bothell, Washington facility and provide it to patients under a risk evaluation and mitigation strategy (REMS).  Breyanzi was designated as an orphan drug on April 1, 2020 and will be manufactured separately for each individual patient.

Categories: Biotechnology, FDA
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