BeiGene Receives European Commission Approval for BRUKINSA (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

BeiGene, Ltd. announced that the European Commission (EC) has granted marketing authorization for BRUKINSA (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. This marks the fourth indication in the European Union (EU) for BRUKINSA, which is now approved to treat more patient populations in the EU than any other Bruton’s tyrosine kinase (BTK) inhibitor.

“With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union. BRUKINSA is now the first BTK inhibitor approved in this indication and has the broadest label of any medicine in its class globally,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “This milestone marks a significant advancement in our efforts to combat the disease by providing a new and effective treatment option to patients who have either failed to respond to initial therapies or have experienced a relapse.”

The EC approval is based on positive results from ROSEWOOD (NCT03332017), a global, randomized, open-label Phase 2 study of BRUKINSA 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 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. Responses were durable with 18-month landmark duration of response (DOR) of 69.3% in the BRUKINSA combination arm.

Additionally, the median progression-free survival (PFS) for patients treated with BRUKINSA plus obinutuzumab was 28.0 months, compared to 10.4 months for patients treated with only obinutuzumab (HR: 0.50 [95% CI: 0.33, 0.75]; P = 0.0007).

BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.

“People living with follicular lymphoma often experience relapse and have poor responses to subsequent lines of therapy, making it imperative to improve outcomes,” said Pier Luigi Zinzani, M.D., Ph.D., Full Professor of Haematology at the Institute of Haematology “Seràgnoli,” University of Bologna, Italy. “The results from the ROSEWOOD trial demonstrated a significant clinical benefit of BRUKINSA plus obinutuzumab for patients with relapsed or refractory follicular lymphoma. BRUKINSA is a chemotherapy-free, oral treatment option that can be a practice-changing option for eligible patients with relapsed or refractory follicular lymphoma.”

In addition to R/R FL, BRUKINSA is approved in the EU as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia, for adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, and for adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.

Gerwin Winter, Senior Vice President, Head of Europe at BeiGene noted, “We have made great progress in making BRUKINSA available to eligible patients with hematological malignancies globally, and this approval is a testament to our continued commitment to bring this much needed treatment option to patients in Europe and around the world. We hope that this approval will have a positive impact on the lives of many people living with follicular lymphoma in the European Union and their families.”

BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities including in the United States (U.S.) and China. Additionally, BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative (NASWSI).

BRUKINSA is approved in more than 65 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland in selected indications and under development for additional indications globally. Product information may differ from country to country. Prescribers should consult the product information approved in their respective countries. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.