BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA Indication

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), 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.

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Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene commented that BRUKINSA is the first Bruton's tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and BeiGene plans to continue worldwide regulatory submissions based on the ROSEWOOD results (Photo: Business Wire)

“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%.