BeiGene drug wins U.S. FDA approval for rare form of lymphoma

Credit: REUTERS/Jason Reed

The U.S. Food and Drug Administration on Thursday approved BeiGene Ltd's lymphoma treatment, validating the China-based drugmaker's strategy of largely using data from trials held outside the United States to file for approval.

Adds details on BeiGene, background

Nov 14 (Reuters) - The U.S. Food and Drug Administration on Thursday approved BeiGene Ltd's 6160.HK, BGNE.O lymphoma treatment, validating the China-based drugmaker's strategy of largely using data from trials held outside the United States to file for approval.

The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21% Caucasian, and between 10% to 15% were from the United States, BeiGene said.

The FDA granted accelerated approval to the capsules for treatment of adult patients with mantle cell lymphoma, who have received at least one prior therapy. (https://bit.ly/2QkvjHu)

Mantle cell lymphoma is a rare, aggressive form of non-Hodgkin lymphoma, a blood cancer that most often affects men aged over 60. The company estimates between 3,000 and 4,000 new patients were diagnosed in the United States in 2015.

BeiGene's new treatment will compete with Johnson & Johnson JNJ.N and AbbVie Inc's ABBV.N Imbruvica and AstraZeneca's AZN.L Calquence, as well as Celgene Corp's CELG.O Revlimid.

Last month Amgen Inc AMGN.O said it would take a 20.5% stake in BeiGene to expand its presence in the world's most populous country.

China is the world's second largest pharmaceutical market and with a 700-person sales force and 600 employees in clinical development in the country, BeiGene is well positioned to sell drugs from American pharmaceutical companies in the Asian market.

(Reporting by Tamara Mathias and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta)

((Tamara.Mathias@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 806749 1208;))

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