FDA Grants Accelerated Approval to Zanubrutinib for Relapsed, Refractory Follicular Lymphoma

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The application was previously granted fast track designation and orphan drug designation.

The FDA has granted accelerated approval to zanubrutinib (Brukinsa; BeiGene) in combination with obinutuzumab (Gazyva; Genentech) for patients with relapsed or refractory follicular lymphoma (FL) following 2 or more lines of systemic therapy.1

FDA headquarters, United States Food and Drug Administration (FDA), federal agency

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The approval is based on data from the ROSEWOOD trial (NCT03332017), an open-label, multicenter, randomized trial with 217 adult patients diagnosed with relapsed or refractory FL after at least 2 prior systemic treatments, including an anti-CD20 antibody and an alkylating agent. Patients were randomly assigned 2:1 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, ranging from 2 to 11.2

The primary endpoint was overall response rate (ORR) as determined by independent central review, while secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.2

According to the trial results published in the Journal of Clinical Oncology in November of 2023, the study met its primary endpoint with an ORR of 69% (95% CI: 61,76) in the zanubrutinib arm vs 46% (95% CI: 34, 58) in the obinutuzumab monotherapy arm. Furthermore, the complete response rate in the investigational arm was 39% vs 19% in the monotherapy arm. Median PFS was 28 months in the intervention arm vs 10.4 months in the monotherapy arm.2

With a 19-month median follow-up, the median DOR was not reached in the combination arm (95% CI: 25.3 months, NE) and was 14 months (95% CI: 9.2, 25.1) in the obinutuzumab monotherapy arm. The estimated DOR rate at 18 months in the intervention arm was 69% (95% CI: 58, 78).2

About the ROSEWOOD Trial

Trial name: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma (ROSEWOOD)

ClinicalTrials.gov ID: NCT03332017

Sponsor: BeiGene

Completion date (estimated): October 31, 2024

Based on these findings, the investigators concluded that the combination of zanubrutinib and obinutuzumab had a superior ORR compared with obinutuzumab alone, and demonstrated meaningful activity and a manageable safety profile in patients with relapsed or refractory FL.2

Across multiple clinical trials with 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 patients with FL who received zanubrutinib.1

“[Zanubrutinib and obinutuzumab] had a favorable benefit-risk profile compared with [obinutuzumab], and represents a potential combination therapy for patients with [relapsed or refractory] FL,” the authors wrote.2

The recommended dosage of zanubrutinib is either 160 mg or 320 mg taken orally once daily until disease progression or unacceptable toxicity. The application was previously granted fast track designation and orphan drug designation.1

References
1. FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma. News release. FDA. March 7, 2024. Accessed March 7, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
2. Zinzani PL, Mayer J, Flowers CR, Bijou F, et al. ROSEWOOD: A phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023;41(33):5107-5117. doi:10.1200/JCO.23.00775
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