BeiGene, Ltd. (BGNE), a clinical-stage pharmaceutical company, announced Wednesday that the U.S. Food and Drug Administration has accepted for review its supplemental new drug application or sNDA for BRUKINSA (zanubrutinib) in combination with obinutuzumab as a treatment for relapsed or refractory follicular lymphoma.
BRUKINSA is a small molecule inhibitor of Bruton's tyrosine kinase or BTK that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
BRUKINSA was previously granted Fast Track and Orphan designation for this indication. Under the Prescription Drug User Fee Act, the FDA has assigned a target action date in the first quarter of 2024.
The sNDA filing for BRUKINSA for the treatment of adult patients with relapsed or refractory or R/R follicular lymphoma or FL after at least two prior lines of therapy is based on results from the Phase 2 ROSEWOOD study (NCT03332017).
The trial included 217 patients with pre-treated R/R non-Hodgkin FL, in which 145 received BRUKINSA plus obinutuzumab and 72 patients received 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 versus 45.8% respectively.
Mehrdad Mobasher, Chief Medical Officer, Hematology, said, "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."
BRUKINSA is approved in more than 65 markets in selected indications and under development for additional approvals globally.
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.
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