The European Commission (EC) has granted marketing authorisation to BeiGene’s Brukinsa (zanubrutinib) plus obinutuzumab to treat relapsed or refractory (R/R) follicular lymphoma (FL) in adults.

This combination regimen is indicated for usage in FL patients who have already received a minimum of two lines of systemic treatment. 

The latest development is based on positive data from the open-label, randomised, international Phase II ROSEWOOD clinical trial of Brukinsa in combination with obinutuzumab versus obinutuzumab alone.

The Brukinsa combination regimen offered a 69% overall response rate compared to 45.8% in the obinutuzumab arm, with almost 20 months of median follow-up. 

Durable responses were reported in the Brukinsa combination group, with an 18-month duration of response of 69.3%.

Median progression-free survival was 28 months in the Brukinsa plus obinutuzumab arm versus 10.4 months on obinutuzumab alone.

The Brukinsa combination regimen was also found to be well-tolerated, with safety data in line with prior trial data.

A small molecule Bruton’s tyrosine kinase inhibitor, Brukinsa is being evaluated as a single agent and a combination regimen for treating B-cell malignancies. 

BeiGene haematology chief medical officer Mehrdad Mobasher stated: “With this approval, we are excited to announce that Brukinsa will become available as a treatment option for patients with follicular lymphoma in the European Union.” 

“This milestone marks a significant advancement in our efforts to combat the disease by providing a new and effective treatment option to patients who have either failed to respond to initial therapies or have experienced a relapse.”

The latest approval is the fourth indication for Brukinsa in the European Union.

Brukinsa is currently approved in more than 65 markets.

In July 2023, the US Food and Drug Administration accepted for review BeiGene’s supplemental new drug application for a Brukinsa combination to treat R/R FL.