BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA Indication

BeiGene, a global biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. BRUKINSA was previously granted Fast Track and Orphan designation for this indication. The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act.

“Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. We are therefore pleased that BRUKINSA is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the ROSEWOOD results,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology. “Importantly, we are grateful to the people living with relapsed or refractory follicular lymphoma who chose to participate in the ROSEWOOD study.”

The sNDA filing in FL is based on results from the Phase 2 ROSEWOOD study (NCT03332017) that included 217 patients with pre-treated R/R non-Hodgkin FL (145 receiving BRUKINSA plus obinutuzumab and 72 patients receiving obinutuzumab monotherapy). In the primary ROSEWOOD analysis at a median follow-up of 12.5 months, BRUKINSA plus obinutuzumab demonstrated superior efficacy to obinutuzumab monotherapy with a 68.3% overall response rate (ORR) versus 45.8% respectively (p = 0.0017). Responses were durable with 18-month landmark duration of response (DOR) of 69.3%.

Safety results from the ROSEWOOD study were consistent with previous studies of both medicines. The most common treatment emergent adverse events reported in the primary analysis for the combination arm compared with the obinutuzumab alone arm were diarrhea (18.2% vs 16.9%), fatigue (15.4% vs 14.1%), and pyrexia (13.3% vs 19.7%).

Longer-term data included in the sNDA demonstrated the efficacy benefit for BRUKINSA plus obinutuzumab persisted at a median follow-up of 20.2 months, with an ORR of 69.0% versus 45.8% for obinutuzumab monotherapy (p = 0.0012). Additionally, the combination of BRUKINSA and obinutuzumab reduced the risk of disease progression or death by 50% compared with obinutuzumab alone (HR 0.50; 95% CI 0.33-0.75).

BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the European Union and China. 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.

BRUKINSA is approved in more than 65 markets including the U.S., China, European Union, Great Britain, Canada, Australia, South Korea, and Switzerland in selected indications and under development for additional approvals globally. The product information may differ from country to country. Prescribers should consult the product information approved in their respective country. The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.