Posted by Michael Wonder on 07 Mar 2024
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
7 March 2024 - Today, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The regimen was evaluated in BGB-3111-212 (ROSEWOOD), an open-label, multi-centre, randomised trial that enrolled 217 adult patients with relapsed or refractory follicular lymphoma after at least 2 prior systemic treatments.
