BeiGene Ltd.'s experimental blood cancer drug zanubrutinib is the first of the Chinese drug developer's therapies to be accepted for review by the U.S. Food and Drug Administration.
Zanubrutinib is intended to treat a rare type of non-Hodgkin lymphoma called mantle cell lymphoma in patients who have received at least one prior treatment. Non-Hodgkin lymphoma is a cancer of the white blood cells.
The FDA will make a decision on zanubrutinib by Feb. 27, 2020, via priority review, China-based BeiGene said in an Aug. 21 press release.
Zanubrutinib was granted breakthrough therapy designation by the FDA in January 2019, as well as fast-track status to treat another rare non-Hodgkin lymphoma called Waldenström macroglobulinemia.
The drug candidate is a selective Bruton's tyrosine kinase inhibitor that can control the rate at which certain cells multiply. Its application for approval included data from several early-stage trials, which showed that zanubrutinib reduced cancer in patients.
Zanubrutinib, also under priority review in China, is currently in mid- and late-stage trials comparing the drug to other approved blood cancer therapies, including Johnson & Johnson's Imbruvica, another BTK inhibitor.
