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BeiGene's rare blood cancer drug gets US FDA breakthrough therapy status

BeiGene Ltd.'s medicine zanubrutinib was granted U.S. Food and Drug Administration breakthrough therapy designation to treat a rare form of blood cancer.

The Chinese cancer drug developer said zanubrutinib was granted the status to treat patients with mantle cell lymphoma who have received at least one prior therapy.

Mantle cell lymphoma is an aggressive and rare form of non-Hodgkin lymphoma, a cancer of the white blood cells.

The FDA's breakthrough therapy status allows for expedited development and review of drugs that show improvement compared to existing therapies for treating a serious or life-threatening disease.

Zanubrutinib, which is being studied in several clinical trials, has already secured a priority review by Chinese regulators for mantle cell lymphoma and for treating chronic lymphocytic leukemia and small lymphocytic lymphoma in Chinese patients whose cancer had returned or was resistant to treatment.

The drug has also received the FDA's fast-track status to treat Waldenström macroglobulinemia, another rare type of non-Hodgkin lymphoma.