Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA demonstrated a numerically higher very good partial response rate and a favourable safety profile compared to ibrutinib.
BeiGene today announced the CHMP of the EMA has adopted a positive opinion, recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy.
