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 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 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 hematology 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."
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By avoiding large U.S. trials, drugmakers are more likely to quickly
enroll 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.
"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.
(Reporting by Tamara Mathias and Manojna Maddipatla in Bengaluru;
Editing by Shounak Dasgupta)
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