Zanubrutinib Plus Obinutuzumab Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma

Zanubrutinib Plus Obinutuzumab Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma

Zanubrutinib (Brukinsa) with obinutuzumab (Gazyva) has received accelerated approval from the FDA for the treatment of relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

This FDA approval was based on findings from Study BGB-3111-212 (ROSEWOOD; NCT03332017), according to a statement from the FDA. In this open-label, multicenter, randomized trial, researchers assessed data from 217 adult patients with relapsed or refractory follicular lymphoma who previously received at least 2 systemic treatments.

Patients in this study were randomized in a 2:1 fashion to receive either 160 mg of zanubrutinib orally twice per day until unacceptable toxicity or disease progression plus obinutuzumab, or obinutuzumab alone. Patients received a median of 3 prior lines of therapy (range, 2-11).

The efficacy of zanubrutinib plus obinutuzumab was based on the overall response rate (ORR) and duration of response (DOR), as determined by an independent review committee.

Patients assigned zanubrutinib plus obinutuzumab had an ORR of 69% (95% CI, 61%-76%) compared with 46% (95% CI, 34%-58%) in those assigned obinutuzumab alone (2-sided P = .0012). During a median follow-up of 19.0 months, the zanubrutinib plus obinutuzumab group did not reach the median DOR (95% CI, 25.3-NE), whereas the median DOR was 14.0 months (95% CI, 9.2-25.1) for the obinutuzumab alone group. At 18 months, the estimated DOR was 69% (95% CI, 58%-78%) in the combination arm.

In clinical trials assessing the efficacy of zanubrutinib, the most common adverse reactions, occurring in at least 30% of patients, included decreased platelet counts (41%), decreased neutrophil counts (51%), hemorrhage (32%), upper respiratory tract infection (38%), and musculoskeletal pain (31%). Serious adverse reactions were observed in 35% of patients with follicular lymphoma who were treated with zanubrutinib plus obinutuzumab, according to the statement from the FDA.

The agency recommends a 160 mg dose of zanubrutinib to be taken orally twice per day or a 320 mg dose taken orally once per day until unacceptable toxicity or disease progression.

Reference

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