The US Food and Drug Administration (FDA) has approved BeiGene Ltd’s lymphoma treatment, validating the China-based drug-maker’s strategy of largely using data from trials held outside the US to file for approval. Reuters Health reports that 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 US, 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.
The report says 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 US,” Jane Huang, chief medical officer for haematology at BeiGene is quoted in the report as saying. “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.”
The report says by avoiding large US trials, drug makers 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.
[link url="https://www.reuters.com/article/us-beigene-fda/chinas-beigene-gets-fda-approval-for-drug-to-treat-rare-form-of-lymphoma-idUSKBN1XO2UI"]Reuters Health report[/link]