FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

Zanubrutinib (Brukinsa) with obinutuzumab (Gazyva) is now indicated for relapsed or refractory follicular lymphoma (FL) after 2 or more lines of systemic therapy. The regimen was evaluated in the ROSEWOOD trial, an open-label, multicenter, randomized study in which 217 adult patients with relapsed or refractory FL were randomized (2:1) to receive either zanubrutinib 160 mg PO bid plus obinutuzumab or obinutuzumab montherapy, until disease progression or unacceptable toxicity. Efficacy was based on overall response rate and duration of response. Tap for more details ...