FDA Reviewing Brukinsa Combo for Relapsed/Refractory Follicular Lymphoma


The Food and Drug Administration accepted a supplemental New Drug Application for Brukinsa plus Gazyva to treat patients with relapsed or refractory follicular lymphoma.

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The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application for Brukinsa (zanubrutinib) plus Gazyva (obinutuzumab) for the treatment of adults with relapsed and/or refractory follicular lymphoma, according to BeiGene, the manufacturer of the drug.

By granting the supplemental New Drug Application, the FDA agrees to review a previously approved therapy to be introduced for another subset of patients. In this instance, the FDA granted an approval decision date of early 2024.

“Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. We are therefore pleased that Brukinsa is the first Bruton's tyrosine kinase (BTK) inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the ROSEWOOD results,” said Dr. Mehrdad Mobasher, chief medical officer, Hematology, in a company-issued press release.

Brukinsa works by inhibiting BTK, a type of enzyme that plays a key role in the signaling, growth and survival of cancer cells in patients with B-cell malignancies like follicular lymphoma, which is a type of non-Hodgkin lymphoma. Earlier this year, the drug gained FDA approval for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic leukemia. In 2021, Brukinsa was approved for patients with marginal zone lymphoma.

This New Drug Application, which is specifically for patients who underwent two or more prior lines of treatment, was granted based off findings from the phase 2 ROSEWOOD trial, which included 217 patients with pretreated, relapsed or refractory (meaning that the disease either got worse on therapy or never responded to therapy in the first place), non-Hodgkin lymphoma: 145 patients received Brukinsa plus Gazyva, while 72 received Gazyva only.

At an average follow-up of 12.5 months, a higher percentage of patients in the Brukinsa-containing arm experienced their disease shrinking or disappearing — a statistic commonly referred to as overall response rate, and in this case, was the main goal of the study — than the Gazyva group, at 68.3% and 45.8%, respectively. At the 18-month mark, 69.3% of patients were still responding to the Brukinsa/Gazyva combination.

The Brukinsa combination continued to outperform single-agent Gazyva at an average follow-up of 20.2 months, with overall response rates of 69% and 45.8% in the Brukinsa-containing and Gazyva-only groups. The researchers on the study also found that adding Brukinsa to Gazyva reduced the risk of disease progression or death by 50%, compared to Gazyva alone.

Regarding side effects, those observed in the ROSEWOOD trial were consistent with what was documented in prior studies of each drug.

READ MORE: Brukinsa Offers Better Response and Less Toxicity for CLL and SLL Treatment, But a Cure Is Still Needed

The most common side effects in ROSEWOOD were diarrhea (experienced by 18.2% of patients in the two-drug group and 16.9% in the monotherapy group), fatigue (15.4% and 14.1%) and fever (13.3% and 19.7%).

Researchers involved in ROSEWOOD also plan on examining progression-free survival (time from treatment until death or disease worsens), overall survival (time from treatment until death of any cause), complete response rate and complete metabolic response (percentage of patients whose disease disappears after treatment, as determined by certain tests), health-related quality of life, time to response and occurrence and severity of side effects. The estimated study completion date is November 2023, according to the study’s listing on clinicaltrials.gov.

“Importantly, we are grateful to the people living with relapsed or refractory follicular lymphoma who chose to participate in the ROSEWOOD study,” Mobasher said.

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