FDA Approves Zanubrutinib for Patients With Relapsed/Refractory Follicular Lymphoma

On March 7, 2024, the US Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib with obinutuzumab treatment for patients with relapsed or refractory (R/R) follicular lymphoma (FL), following 2 or more lines of systemic therapy.

This accelerated approval is based on an open-label, multicenter, randomized trial that enrolled 217 adult patients with R/R FL after at least 2 prior systemic treatments. Patients were randomized on a 2-to-1 basis to receive either zanubrutinib 160 mg orally twice daily until disease progression or unacceptable toxicity plus obinutuzumab, or obinutuzumab alone. The median number of prior lines of therapy was 3, with a range of 2 to 11. Investigators measured efficacy based on overall response rate (ORR) and duration of response (DOR), which was determined by an independent review committee. 

Results determined that the ORR was 69% (95% confidence interval [CI], 61 to 76) in the zanubrutinib obinutuzumab arm and 46% (95% CI, 34 to 58) in the obinutuzumab alone arm. After a median follow-up of 19 months, the median DOR was not reached in the zanubrutinib obinutuzumab arm (95% CI, 25.3 months to not estimable [NE]) and was 14 months (95% CI; 9.2 to 25.1) for patients receiving obinutuzumab monotherapy. It was also noted that the estimated DOR rate at 18 months was 69% (95% CI, 58 to 78) in the zanubrutinib obinutuzumab arm.

Drug safety was determined after examining clinical trials of zanubrutinib. The most common adverse reactions (≥30%), including laboratory abnormalities, were decreased neutrophil counts (51%) and platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Serious adverse reactions occurred in 35% of participants with FL who received zanubrutinib obinutuzumab.

Source:

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma. Published online March 7, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma