FDA approves drug made by China's BeiGene to treat rare form of lymphoma

The U.S. Food and Drug Administration (FDA) Thursday approved BeiGene Ltd's drug to treat a rare form of blood cancer, validating China-based drugmaker's strategy of largely using data from trials held outside the U.S. to file for approval.

The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma (MCL) enrolled in two studies. About three-quarters of the patients were Asian and 21 percent Caucasian, while 10-15 percent were from the United States, BeiGene said.

[File photo: VCG]

The FDA granted accelerated approval to the capsules for treatment of MCL in adults who have received at least one prior therapy.

MCL is a rare, aggressive form of non-Hodgkin lymphoma, a blood cancer that most often affects men aged over 60 years. 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."

By avoiding large U.S. trials, drugmakers are more likely to quickly enroll patients in their studies, particularly for rare diseases like MCL 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."