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.
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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