BeiGene: CHMP Issues Positive Opinion Recommending Approval Of BRUKINSA - Quick Facts

(RTTNews) - BeiGene (BGNE) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of BRUKINSA for the treatment of adult patients with chronic lymphocytic leukemia. The European Commission will consider the Marketing Application, with a final decision expected within 67 days of receipt of the CHMP opinion.

BeiGene noted that, last month, CHMP issued a positive opinion recommending approval of BRUKINSA for the treatment of adult patients with MZL who have received at least one prior anti-CD20-based therapy.

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