Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks

1. The Food and Drug Administration (FDA) granted an accelerated approval to zanubrutinib (Brukinsa), developed by BeiGene USA, Inc., in combination with obinutuzumab (Gazyva) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
2. Based on the open-label, multicenter, randomized phase 2 ROSEWOOD study (NCT03332017), Brukinsa demonstrated significant improvements in ORR compared to obinutuzumab alone, with 69% vs. 46%, respectively. Median duration of response at 18 months was also higher in the Zanubrutinib plus Obinutuzumab arm.
3. Brukinsa becomes the first BTK inhibitor approved to treat follicular lymphoma in the U.S. and boasts the broadest label within its drug class across various hematology indications.
4. Despite facing competition from much-touted CAR-T cell therapies like Novartis’ Kymriah and Gilead Sciences’ Yescarta, as well as off-the-shelf CD20xCD3 bispecific therapies such as Roche’s Lunsumio and AbbVie’s Epkinly, Brukinsa offers another treatment option without the need for patient monitoring for cytokine release syndrome.
5. Brukinsa's approval in follicular lymphoma comes as AbbVie and Johnson & Johnson's first-in-class BTK inhibitor Imbruvica faced setbacks, including the failure of the phase 3 SELENE study in marginal zone lymphoma.
6. As part of the accelerated approval, BeiGene must further prove Brukinsa's efficacy through confirmatory studies like the ongoing phase 3 MAHOGANY trial.