FDA Approvals Roundup: Brukinsa

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New indications
Brukinsa nabs accelerated approval for previously treated marginal zone lymphoma
BeiGene’s Brukinsa (zanubrutinib) has received accelerated approval for expanded use in treating relapsed or refractory marginal zone lymphoma (MZL) in previously treated adults.

Approval of Brukinsa was based on efficacy findings from two single-arm clinical trials for which overall response rate (ORR) the primary endpoint. In the multicenter, Phase 2 MAGNOLIA trial, 66 patients from the indicated population and with different subtypes were evaluated. Assessments using CT scan showed an ORR of 56% (complete response [CR], 20%), and assessments using PET-CT scan showed an ORR of 67% (CR, 26%). Median duration of response (DoR) was not reached at the median follow-up time of 8.3 months. In all, 85% of responders were still in remission at 12 months. Responses were seen across all subtypes.

Efficacy was also assessed in a global, Phase 1/2 trial that included 20 patients from the indicated population and with different subtypes. Patients assessed using CT scan showed an ORR of 80% (CR, 20%). Median DoR was not reached at the median follow-up time of 31.4 months. At 12 months, 72% of responders were still in remission.

Brukinsa was first approved in 2019 for treating mantle cell lymphoma and received full approval 2 weeks ago as a treatment for Waldenström’s macroglobulinemia.

The indication was approved under accelerated approval based on ORR data. Continued approval for this indication may depend on findings from ongoing randomized, controlled confirmatory trials.

FDA Approvals Roundup: Brukinsa

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