EMA Issues Positive Opinion on Zanubrutinib for CLL

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of zanubrutinib for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

The CHMP recommendation is based on two global head-to-head phase III clinical trials in which zanubrutinib demonstrated superior efficacy: the ALPINE study compared zanubrutinib to ibrutinib in patients with relapsed or refractory CLL, and the SEQUOIA trial compared zanubrutinib to bendamustine plus rituximab in patients with treatment-naïve CLL.

Both the ALPINE and SEQUOIA studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand, and multiple countries in Europe.

Following the CHMP positive opinion, the European Commission will consider the Marketing Application of the manufacture of the drug, with a final decision expected within 67 days of the CHMP opinion. The decision will be applicable to all 27 member states of the European Union (EU) plus Iceland and Norway.

Zanubrutinib is currently approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemo-immunotherapy. In September 2022, the CHMP issued a positive opinion recommending approval of zanubrutinib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

Source: Business Wire, October 2022