Industry News Archive

FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma

On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

FDA granted this application priority review and zanubrutinib received orphan product and breakthrough therapy designations for treatment of MCL. 

Read FDA announcement.

Posted 11/15/2019

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