BeiGene Gets CHMP Backing of Brukinsa in Waldenstrom's Macroglobulinemia
September 17 2021 - 8:50AM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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