Marketing authorization has been granted to a drug to treat relapsed/refractory (R/R) marginal zone lymphoma (MZL) without chemotherapy, it was announced today (November 2).
The European Commission (EC) gave the authorization to biotech company, BeiGene, for Brukinsa (zanubrutinib), which treats adults with the condition who have received at least one prior anti-CD20-based therapy.
The approval is applicable to all 27 member states of the European Union (EU), plus Iceland and Norway. BeiGene is focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide.
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.
Mehrdad Mobasher, chief medical officer of hematology at BeiGene, said: “We are proud of what this approval means for European MZL patients, who previously did not have an approved BTK inhibitor as a treatment option for this rare hematological malignancy.
“This milestone builds on the track record we’ve built with Brukinsa to date,
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