The Food and Drug Administration has accepted for Priority Review the supplemental New Drug Application (sNDA) for zanubrutinib for the treatment of adult patients with marginal zone lymphoma who have received at least 1 prior anti-CD20-based therapy.
The sNDA submission is supported by data from the single-arm, open-label, multicenter, phase 2 MAGNOLIA trial (ClinicalTrials.gov: NCT03846427), which assessed the efficacy and safety of zanubrutinib, a Bruton tyrosine kinase (BTK) inhibitor, in 68 adults with relapsed or refractory marginal zone lymphoma. Patients received zanubrutinib 160mg orally twice a day. The primary endpoint was overall response rate (ORR) determined by independent central review.
With a median follow-up time of 10.7 months, results showed that among the 66 evaluable patients, the ORR was 74.2% (95% CI, 62.0-84.2), with 24.2% (n=16) of patients achieving complete response and 50% (n=33) having partial response. Progression free survival (PFS) rate at 6 and 9 months was 80% and 67%, respectively; overall survival rate at 12 months was 94%. Responses were generally consistent across all subgroups, including high-risk subgroups.
As for safety, the most common adverse events (10% or more) included diarrhea (20.6%), contusion (19.1%), constipation (13.2%), neutropenia (13.2%), pyrexia (11.8%), upper respiratory tract infection (11.8%), thrombocytopenia (10.3%), and nausea (10.3%).
The sNDA submission also includes data from a global phase 1/2 trial (ClinicalTrials.gov: NCT02343120) in patients with B-cell malignancies, along with pooled safety data from 847 patients with B-cell malignancies treated with zanubrutinib in 7 clinical trials.
A Prescription Drug User Fee Act (PDUFA) target date of September 19, 2021 has been set for the application.
Zanubrutinib is marketed under the trade name Brukinsa® and is currently indicated for the treatment of mantle cell lymphoma in adult patients who have received at least 1 prior therapy.
- BeiGene announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application for Brukinsa® (zanubrutinib) in marginal zone lymphoma. [press release]. Cambridge, MA & Beijing, China: BeiGene, Ltd.; May 19, 2021.
- BeiGene announces data on Brukinsa® (zanubrutinib) from phase 2 trial in marginal zone lymphoma and phase 3 trial in chronic lymphocytic leukemia or small lymphocytic lymphoma at the 62nd ASH Annual Meeting. [press release]. Cambridge, MA: BeiGene, Ltd.; December 6, 2020.