FDA Grants Priority Review to Zanubrutinib as Therapy for Pretreated Marginal Zone Lymphoma
A supplemental new drug application for zanubrutinib (Brukinsa) as therapy for patients with marginal zone lymphoma (MZL) who have received 1 or more prior anti-CD20–based therapies was accepted and granted priority review by the FDA, according to the company responsible for developing the agent, Beigene, Ltd.1 The data supporting the filing come from the single-arm, open-label, multicenter, phase 2 MAGNOLIA trial (NCT03846427), which is examining the agent in patients with relapsed/refractory (R/R) MZL and is supported further by a global phase 1/2 trial (NCT02343120) in patients with B-cell malignancies. “This is our first regulatory submission in MZL, a serious disease diagnosed in more than 2000 patients every year in the US, with no clear standard of care. In clinical trials, Brukinsa has demonstrated promising efficacy and tolerability in MZL and presents a potential new option for MZL,” Jane Huang, MD, Chief Medical Officer of Hematology at BeiGene, said in a press release. “We look forward to continuing our communications with the FDA in the coming months as we work on advancing the broad global development program for our potentially best-in-class BTK inhibitor.”