BeiGene Gets FDA Priority Review of Brukinsa in Marginal Zone Lymphoma

 BeiGene Ltd. on Wednesday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of Brukinsa in adults with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

The Beijing biotechnology company said there is currently no clear standard of care for marginal zone lymphoma, a group of slow-growing lymphomas that account for roughly 8% of all non-Hodgkin's lymphoma cases.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. BeiGene said the agency set a target action date of Sept. 19 for its application.

The FDA previously approved Brukinsa for the treatment of mantle cell lymphoma in adults who have received at least one prior therapy.

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