Positive CHMP Opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma- BeiGene.

“Follicular lymphoma remains an incurable disease and an ongoing challenge for healthcare providers. Despite advances in the treatment landscape, patients often relapse and experience shorter response times to subsequent treatments,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “Today’s positive CHMP opinion is a testament to our continued commitment to bringing innovative medicines to patients and demonstrates the value of Brukinsa, which – if approved in FL – will become the BTK inhibitor with the broadest label in the EU.”

The CHMP recommendation is based on positive results from the ROSEWOOD study and supported by the BGB-3111-GA101-001 study . The pivotal ROSEWOOD study (BGB-3111-212; NCT03332017) is an ongoing global Phase II study of Brukina plus obinutuzumab compared with obinutuzumab alone in 217 patients with R/R FL who received at least two prior lines of systemic therapy. In the randomized, open-label study, the overall response rate was 69.0% in the Brukinsa plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (p = 0.0012), with a median follow-up of approximately 20 months. Brukinsa plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.

BGB-3111-GA101-001 (NCT02569476) is a Phase 1b study designed to assess the safety, tolerability and antitumor activity of Brukinsa with obinutuzumab in participants with B-cell lymphoid malignancies.

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

Brukinsa is currently approved in the EU as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia and as monotherapy for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. It is also approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

Follicular Lymphoma is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22 percent of all NHL cases. Across Europe, over 122,000 people each year are diagnosed with NHL.FL is a slow-growing cancer but can become more aggressive over time. While FL remains incurable, people with the condition can live a long time. The five-year survival rate is about 90 percent, and approximately half of people diagnosed with FL can live with the disease for nearly 20 years.