The Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) plus Gazyva (obinutuzumab) for the treatment of patients with relapsed or refractory follicular lymphoma who have undergone two or more prior lines of systemic therapy, the agency announced.
The approval was based off findings from the BGB-3111-212 (ROSEWOOD) clinical trial, that included 217 adults with pretreated relapsed or refractory follicular lymphoma. Two thirds of the patients were randomly assigned to receive Brukinsa plus Gazyva twice a day until disease progression or unacceptable toxicity, while the other third of participants were assigned to receive Gazyva alone.
The overall response rate, which indicates the percentage of patients whose disease shrinks or disappears from therapy, was 69% in the group of patients who received both drugs, and 46% in the patients who received Gazyva alone.
At a median follow-up of 19 months, the median duration of response was not reached in the Brukinsa/Gazyva arm (indicating that not enough patients stopped responding to treatment to calculate an average), whereas it was 14 months in the Gazyva arm. An estimated 69% of patients in the Brukinsa/Gazyva group were still responding at 18 months.
Across all clinical trials of Brukinsa, the most common side effects that occurred in 30% or more of patients were decreased neutrophil counts and platelet counts, upper respiratory tract infection, hemorrhage and musculoskeletal pain. Thirty-five percent of patients with follicular lymphoma who were treated with Brukinsa plus Gazyva experienced a serious side effect.
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