BeiGene Brukinsa Recommended for Approval From European Medicines Agency Committee
October 13 2023 - 12:46PM
Dow Jones News
By Denny Jacob
BeiGene's brukinsa received a positive opinion recommending its
approval from an European Medicines Agency committee.
The biotechnology company said the Committee for Medicinal
Products for Human Use issued its opinion of brukinsa in
combination with obinutuzumab as a treatment for adult patients
with relapsed or refractory follicular lymphoma, the second most
common type of non-Hodgkin lymphoma, who have received at least two
prior lines of systemic therapy.
The European Commission will consider BeiGene's market
applications following the opinion, with a final decision expected
in a little over two months. The decision will be applicable to all
27 member states of the European Union, as well as Iceland and
Norway.
Brukinsa is currently approved in the EU as a monotherapy for
the treatment of adult patients with chronic lymphocytic leukemia
and as a monotherapy for the treatment of adult patients with
marginal zone lymphoma who have received at least one prior
anti-CD20-based therapy. It is also approved in the EU for the
treatment of adult patients with Waldenström's macroglobulinemia
who have received at least one prior therapy or for the first-line
treatment of patients unsuitable for chemo-immunotherapy.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
October 13, 2023 12:31 ET (16:31 GMT)
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