BeiGene's anti-cancer drug expected to benefit US patients

The US Food and Drug Administration has accepted the application of Huangpu biopharmaceutical enterprise BeiGene for approval of the supplemental new drug Brukinsa (zanubrutinib) in the treatment of Waldenstrom macroglobulinemia.

Waldenstrom macroglobulinemia is a rare indolent lymphoma with significant morbidity. It occurs in less than 2 percent of patients with non-Hodgkin's lymphoma and there are about 5,000 US patients diagnosed with Waldenstrom macroglobulinemia annually.

BeiGene is a biopharmaceutical company in Guangzhou's Huangpu district.

Jane Huang, BeiGene's chief medical officer in hematology, said that "We are pleased that the FDA has accepted the supplemental new drug application for Brukinsa in the treatment of Waldenstrom macroglobulinemia. Bruton tyrosine kinase inhibitors have transformed the treatment of the disease in recent years, but discrepancies in response exist in patients of different subtypes, and toxicity can remain an issue".

"We look forward to continuing our communications with the FDA in the coming months and hope that Brukinsa will become a new treatment option for US patients," added Huang.

In addition to the US, zanubrutinib is also under regulatory review as a treatment for patients with Waldenstrom macroglobulinemia in the European Union, Canada, Australia, China and South Korea.

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