BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA Indication - Seite 2

Safety results from the ROSEWOOD study were consistent with previous studies of both medicines. The most common treatment emergent adverse events reported in the primary analysis for the combination arm compared with the obinutuzumab alone arm were diarrhea (18.2% vs 16.9%), fatigue (15.4% vs 14.1%), and pyrexia (13.3% vs 19.7%).ⁱ

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

BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the European Union and China. BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative.

BRUKINSA is approved in more than 65 markets including the U.S., China, European Union, Great Britain, Canada, Australia, South Korea, and Switzerland in selected indications and under development for additional approvals globally. The product information may differ from country to country. Prescribers should consult the product information approved in their respective country. The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.

About ROSEWOOD

ROSEWOOD is a randomized, open-label, Phase 2 study comparing BRUKINSA plus obinutuzumab to obinutuzumab alone in patients with R/R FL who have received two or more lines of therapy. The primary endpoint was ORR assessed by independent central review (ICR) according to the Lugano classification. Select secondary endpoints include investigator-assessed ORR, ICR-reviewed and investigator-assessed DOR and progression-free survival, overall survival, and analysis of safety.

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.