The US Food and Drug Administration (FDA) has accepted for review BeiGene’s supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) plus obinutuzumab to treat relapsed or refractory (R/R) follicular lymphoma (FL).
The treatment is indicated for use in adult R/R FL patients, following a minimum of two previous lines of therapy.
A decision on the approval for the treatment is expected in the first quarter of 2024.
Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor that received fast track and orphan drug designation for R/R FL treatment.
The filing is based on findings from the Phase II ROSEWOOD clinical trial in 217 R/R non-Hodgkin FL patients, who had previously received treatment.
Safety data from the trial were in line with those from prior studies of both therapies.
Longer-term trial findings also showed that the efficacy benefit of Brukinsa plus obinutuzumab continued at a median follow-up of 20.2 months.
BeiGene haematology chief medical officer Mehrdad Mobasher stated: “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.”
The submissions for Brukinsa in the same indication are under review in China, Canada, Switzerland, the European Union and the UK.
The latest development comes after the company entered a licence agreement for DualityBio’s antibody-drug conjugate therapy to treat certain solid tumours.
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