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FDA Accepts sNDA for Fifth Indication of BRUKINSA® by BeiGene

Thursday, July 13, 2023

BeiGene, a global biotechnology company, made an announcement today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib). The application is seeking approval for the combination of BRUKINSA with obinutuzumab as a treatment option for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of therapy. The FDA has set a target action date for the first quarter of 2024, in accordance with the Prescription Drug User Fee Act. BRUKINSA has already received Fast Track and Orphan designation for this particular indication.

Follicular lymphoma is a common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. However, there is positive news regarding BRUKINSA, the first Bruton's tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma. BeiGene, the company developing BRUKINSA, plans to continue worldwide regulatory submissions based on the results of the ROSEWOOD study.

The Phase 2 ROSEWOOD study (NCT03332017) included 217 patients with pre-treated relapsed or refractory non-Hodgkin follicular lymphoma. Out of these, 145 patients received BRUKINSA in combination with obinutuzumab, while 72 patients received obinutuzumab monotherapy. In the primary analysis with a median follow-up of 12.5 months, the combination of BRUKINSA plus obinutuzumab showed superior efficacy compared to obinutuzumab alone. The overall response rate (ORR) was 68.3% for the combination and 45.8% for obinutuzumab monotherapy, indicating a significant difference.

The safety results of the ROSEWOOD study were consistent with previous studies of both BRUKINSA and obinutuzumab. The most commonly reported treatment emergent adverse events in the combination arm were diarrhea (18.2% vs. 16.9% in obinutuzumab monotherapy arm), fatigue (15.4% vs. 14.1%), and pyrexia (13.3% vs. 19.7%).

Longer-term data included in the supplemental new drug application (sNDA) demonstrated the sustained efficacy of BRUKINSA plus obinutuzumab at a median follow-up of 20.2 months. The ORR was 69.0% for the combination, which was significantly higher than the 45.8% ORR observed for obinutuzumab monotherapy. Furthermore, the combination therapy reduced the risk of disease progression or death by 50% compared to obinutuzumab alone (HR 0.50; 95% CI 0.33-0.75).

BeiGene has submitted applications for regulatory approval of BRUKINSA in relapsed or refractory follicular lymphoma to regulatory authorities in the European Union, China, Canada, Switzerland, and the United Kingdom. BRUKINSA is already approved in over 65 markets globally, including the U.S., China, European Union, Great Britain, Canada, Australia, South Korea, and Switzerland, for selected indications. However, the product information may vary from country to country, and prescribers should consult the approved product information in their respective countries.

BeiGene's global development program for BRUKINSA has enrolled more than 4,900 subjects across 29 countries and regions, highlighting its extensive research efforts and commitment to providing potential treatment options for patients with follicular lymphoma.

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