Zanubrutinib
[19] In March 2024, FDA granted accelerated approval to zanubrutinib, in combination with obinutuzumab, for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[22] Efficacy was evaluated in BGB-3111-206 (NCT03206970), a phase II open-label, multicenter, single-arm trial of 86 participants with mantle cell lymphoma (MCL) who received at least one prior therapy.[15][16] The primary efficacy outcome measure in both trials was overall response rate (ORR), as assessed by an independent review committee.[12] In March 2024, the FDA granted accelerated approval to zanubrutinib with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[20] The regimen was evaluated in Study BGB-3111-212 (ROSEWOOD; NCT03332017), an open-label, multicenter, randomized trial that enrolled 217 adult participants with relapsed or refractory follicular lymphoma after at least two prior systemic treatments.