BeiGene Brukinsa Recommended for Approval From European Medicines Agency Committee

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 [e-mail]

(END) Dow Jones Newswires

October 13, 2023 12:31 ET (16:31 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.