BGNE BeiGene Ltd

By Colin Kellaher

BeiGene Ltd. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Brukinsa for the treatment of adults with Waldenstrom's macroglobulinemia, a rare type of non-Hodgkin's lymphoma.

The Beijing biopharmaceutical company said the recommendation covers the treatment of patients who have received at least one prior therapy or the first-line treatment of patients unsuitable for chemo-immunotherapy.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

BeiGene said approval would be its first in Europe for Brukinsa, which has been cleared in various indications in several countries around the world, including the U.S. and China. BeiGene said its European commercial team is preparing to launch the drug.

American depositary receipts of BeiGene, which closed Thursday at $385.24, rose more than 13% in premarket trading Friday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 17, 2021 08:35 ET (12:35 GMT)

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