On May 13, 2024, BeiGene announced that zanubrutinib (Chinese brand name: 百悦泽; international brand name: BRUKINSA), its Bruton's tyrosine kinase (BTK) inhibitor, has been granted conditional approval by the National Medical Products Administration (NMPA) of China for an additional indication. The newly approved indication is the combination of zanubrutinib and obinutuzumab for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.
Basis for Zanubrutinib’s Approval
The conditional approval from the NMPA is supported by data from ROSEWOOD, a global, randomized, open-label, multicenter Phase 2 clinical trial (NCT03332017). The study enrolled 217 patients with R/R FL who had undergone at least two prior lines of systemic therapy, and compared the efficacy of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy. Full conventional approval of this indication will be contingent upon results from a confirmatory Phase 3 randomized controlled trial (BGB-3111-308), which evaluates zanubrutinib in combination with an anti-CD20 antibody against lenalidomide plus rituximab in patients with R/R follicular or marginal zone lymphoma.
About Follicular Lymphoma
Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma (NHL), accounting for 22% of all NHL cases. It has a 5-year survival rate of approximately 90%, and nearly half of patients diagnosed with FL survive for nearly 20 years. Most patients present with advanced-stage disease at diagnosis. As an indolent malignancy, FL tends to become more aggressive over the course of the disease. Patients with first relapsed or refractory FL have a median overall survival (mOS) of up to 10 years, underscoring the critical importance of treatment safety throughout the long disease course. Conventional chemoimmunotherapy regimens are associated with substantial hematologic toxicity and infection risks, creating an urgent unmet need for safer targeted therapies to fulfill patients’ demand for chemotherapy-free treatment options.
Current Landscape of Follicular Lymphoma
Professor Zhu Jun from Peking University Cancer Hospital stated: "In China, the incidence of follicular lymphoma is rising year by year, with a median age at diagnosis of 60–65 years, predominantly affecting middle-aged and elderly patients. For patients with relapsed or refractory follicular lymphoma, zanubrutinib offers an oral, chemotherapy-free therapeutic option. We believe that with this approval, this treatment regimen will become a practice-changing therapy, ushering in a new chemotherapy-free era for follicular lymphoma treatment and is expected to significantly improve patients’ treatment adherence and quality of life."
Notably, zanubrutinib was approved by the European Commission (EC) for the treatment of R/R FL in November 2023, making it the BTK inhibitor with the broadest approved patient population in the European Union. In March 2024, the indication for FL received accelerated approval from the U.S. Food and Drug Administration (FDA), marking the fifth approval for zanubrutinib in B-cell malignancies in the United States.
