Summary
BeiGene, Ltd. (ONC) announced on August 21, 2019, that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zanubrutinib for the treatment of mantle cell lymphoma (MCL) patients who have received at least one prior therapy. This acceptance represents a significant step forward in the drug's potential market entry, following its earlier designation as a Breakthrough Therapy by the FDA for the same indication. The FDA has granted Priority Review for this NDA, indicating the agency believes zanubrutinib meets its criteria for accelerated review. The Prescription Drug User Fee Act (PDUFA) target action date has been set for February 27, 2020, providing investors with a clear timeline for a potential approval decision. This development is crucial for BeiGene as it advances its pipeline and moves closer to commercialization for this important oncology drug.
Key Highlights
- 1FDA accepted New Drug Application (NDA) for zanubrutinib for MCL.
- 2Zanubrutinib is indicated for MCL patients with at least one prior therapy.
- 3FDA granted Priority Review status for the zanubrutinib NDA.
- 4PDUFA target action date set for February 27, 2020.
- 5This follows a prior Breakthrough Therapy designation for zanubrutinib in MCL.
- 6The announcement was made via press release filed as an exhibit to the 8-K.