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FDA Grants Zanubrutinib Priority Review for Relapsed/Refractory Mantle Cell Lymphoma

Gina Columbus @ginacolumbusonc
Published: Wednesday, Aug 21, 2019

The FDA has granted a priority review designation to a new drug application (NDA) for zanubrutinib (BGB-3111) for the treatment of patients with mantle cell lymphoma (MCL) who have received ≥1 prior therapy.1

The application is based on data from an international phase I/II trial (NCT02343120) in patients with B-cell lymphomas, a group of patients with relapsed/refractory MCL in China in a phase II trial (NCT03206970), pooled safety data from 5 clinical trials, and nonclinical data, stated BeiGene, the developer of the investigational BTK inhibitor.

Under the Prescription Drug User Fee Act, the FDA must make a decision on the NDA by February 27, 2020.

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