BeiGene gets USFDA approval for lymphoma drug Brukinsa

BeiGene 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.

New Delhi: 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.

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 the treatment of adult patients with mantle cell lymphoma, who have received at least one prior therapy.

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 U.S. in 2015.

BeiGene's new treatment will compete with Johnson & Johnson and AbbVie Inc's Imbruvica and AstraZeneca's Calquence, as well as Celgene's Revlimid.

The company did not disclose the price of Brukinsa, saying it would be set once the treatment is commercially available in the coming weeks.

"The FDA has assessed our data and they believe that the response rates are applicable to all ethnic groups, and is representative of a population that would be treated in the U.S.," Jane Huang, chief medical officer for haematology at BeiGene told Reuters ahead of the decision.

"We are now incorporating China patients into global clinical trials in a greater proportion, and this is a strategy for us to be able to get our drugs to people around the world as quickly as possible."

By avoiding large U.S. trials, drugmakers are more likely to quickly enrol patients in their studies, particularly for rare diseases like mantle cell lymphoma where companies must compete with rivals testing their novel drugs in the same group of patients.

"The FDA has made public statements ... that they are interested in expediting approvals on drugs for oncology from China," Cowen analyst Yaron Werber said.

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"This is the first time that the FDA ... approved a drug based on efficacy data that is predominantly from China."

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

With a 700-person sales force and 600 employees in clinical development in China, BeiGene is well-positioned to sell drugs from American pharmaceutical companies in the Asian market.

By Tamara Mathias and Manojna Maddipatla

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