FDA Grants Accelerated Approval to Brukinsa for Relapsed or Refractory Follicular Lymphoma

The FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab (Gazyva, Genentech) for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The regimen was evaluated in Study BGB-3111-212 (ClinicalTrials.gov Identifier: NCT03332017), an open-label, multicenter, randomized trial that enrolled 217 adult patients with relapsed or refractory FL after at least two prior systemic treatments. Patients were randomized (2:1) to receive