FDA Acceptance of sNDA for Fifth BRUKINSA Indication Announced by BeiGene

FDA Acceptance of sNDA for Fifth BRUKINSA Indication Announced by BeiGene

Source – Beigene

BeiGene, a prominent global biotechnology company, made a groundbreaking announcement today. The US Food and Drug Administration (FDA) has accepted BeiGene’s supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) in combination with obinutuzumab to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. This is a significant milestone as BRUKINSA was previously granted Fast Track and Orphan designation for this specific use. The FDA has set a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act.

“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 inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the ROSEWOOD results. Importantly, we are grateful to the people living with relapsed or refractory follicular lymphoma who chose to participate in the ROSEWOOD study.”

– Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology

The sNDA filing in FL is founded on data from the Phase II ROSEWOOD study (NCT03332017), which involved 217 patients with pre-treated R/R non-Hodgkin FL. Among them, 145 received BRUKINSA in combination with obinutuzumab, and 72 patients received obinutuzumab monotherapy. The primary ROSEWOOD analysis, conducted at a median follow-up of 12.5 months, revealed that BRUKINSA plus obinutuzumab exhibited superior efficacy compared to obinutuzumab monotherapy, with an overall response rate (ORR) of 68.3% versus 45.8%, respectively (p = 0.0017). The responses were long-lasting, as evidenced by an 18-month landmark duration of response (DOR) of 69.3%.

Safety results from the ROSEWOOD study were consistent with previous research on both medicines. The most common treatment-related adverse events reported in the combination arm, compared to the obinutuzumab alone arm, were diarrhea (18.2% vs. 16.9%), fatigue (15.4% vs. 14.1%), and pyrexia (13.3% vs. 19.7%).

Moreover, the sNDA included longer-term data that demonstrated the continued efficacy of BRUKINSA plus obinutuzumab at a median follow-up of 20.2 months, with an ORR of 69.0% vs. 45.8% for obinutuzumab monotherapy (p = 0.0012). Additionally, the combination of BRUKINSA and obinutuzumab significantly reduced the risk of disease progression or death by 50% compared with obinutuzumab alone (HR 0.50; 95% CI 0.33-0.75).

BeiGene has already submitted BRUKINSA for regulatory review in R/R FL in several countries, including the European Union, China, Canada, Switzerland, and the United Kingdom. Furthermore, the drug has been approved in over 65 markets worldwide, including the US, China, European Union, Great Britain, Canada, Australia, South Korea, and Switzerland, for selected indications, and it is under development for additional approvals worldwide. However, it’s essential to note that product information may differ from country to country, and prescribers should consult the approved product information specific to their respective region. The global BRUKINSA development program has enrolled more than 4,900 subjects to-date in 29 countries and regions, showcasing BeiGene’s commitment to advancing treatment options for patients with follicular lymphoma globally.

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