BeiGene Shares Rise 5% After EC Marketing Authorization for Brukinsa
November 02 2022 - 10:35AM
Dow Jones News
By Chris Wack
BeiGene Ltd. shares were up 5% to $177.49 Wednesday after the
biotechnology company said that the European Commission granted
marketing authorization to Brukinsa zanubrutinib for the treatment
of adult patients with relapsed/refractory marginal zone lymphoma
who have received at least one prior anti-CD20-based therapy.
The company said the approval is applicable to all 27 member
states of the European Union, plus Iceland and Norway.
The EC granted an additional year of marketing protection
because the data submitted for the therapeutic indication
demonstrated a significant clinical benefit for Brukinsa in
comparison with existing therapies, BeiGene said.
The EC approval follows a positive opinion granted in September
by the Committee for Medicinal Products for Human Use of the
European Medicines Agency. In the trial, Brukinsa achieved a high
overall response rate of 68% with 26% of patients achieving
complete remission, as assessed by an Independent Review
Committee.
Brukinsa was generally well-tolerated and safety was consistent
with its established profile.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 02, 2022 10:20 ET (14:20 GMT)
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