Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).
BeiGene Ltd.’s Brukinsa (zanubrutinib) received approval from the U.S. Food and Drug Administration for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
The U.S. Food and Drug Administration accepted a supplemental new drug application for BeiGene’s Bruton’s kinase inhibitor Brukinsa (zanabrutinib) as a potential treatment for Waldenström macroglobulinemia, a type of non-Hodgkin lymphoma.
A late-stage trial failed to show that BeiGene Ltd.’s cancer treatment Brukinsa was superior to Imbruvica, a rival drug from Johnson & Johnson and AbbVie Inc., for treating WM.
China has become one of the most important markets for pharma companies, given the vast patient population and the rising cancer rates, and western pharmaceutical companies are making greater inroads there.
BeiGene Ltd. announced that the commercial-stage biopharmaceutical company’s investigational BTK inhibitor zanubrutinib was granted Fast Track designation by the U.S. FDA for the treatment of patients with Waldenström macroglobulinemia.