China’s BeiGene Gets FDA Approval for Drug to Treat Rare Form of Lymphoma
November 14, 2019
(Reuters) – 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.