EMA Committee Recommends Approval of Zanubrutinib for Follicular Lymphoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency released a statement recommending the approval of zanubrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two previous lines of therapy.

The CHMP recommendation was based on positive findings from the phase II ROSEWOOD study and the phase Ib BGB-3111-GA101-001 study. ROSEWOOD included 217 patients with relapsed or refractory FL who received either zanubrutinib plus obinutuzumab or obinutuzumab alone. Over a median follow-up of approximately 20 months, the zanubrutinib arm achieved an overall response rate of 69% compared with 45.8% in the obinutuzumab arm (P=.0012). The combination was generally well-tolerated and safety results were consistent with previous studies for both therapies, according to a press release from BeiGene, the developer of zanubrutinib.

Currently, zanubrutinib is approved in the European Union (EU) for chronic lymphocytic leukemia and small lymphocytic lymphoma, marginal zone lymphoma, and Waldenström’s macroglobulinemia. It also holds various approvals in the US, China, Great Britain, Canada, Australia, South Korea, and Switzerland, with ongoing development for additional indications.

Following the positive CHMP recommendation, the European Commission will review the marketing authorization for FL. If approved, the indication will apply to the 27 member states of the EU, Iceland, and Norway.

BeiGene, has similar applications for the FL indication under review in the US, China, Canada, Switzerland, and the United Kingdom.