November 14, 2019 / 8:53 PM / 24 days ago

BeiGene drug wins U.S. FDA approval for rare form of lymphoma

Nov 14 (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 just 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. (bit.ly/2QkvjHu) (Reporting by Tamara Mathias and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below