BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma - Seite 2

BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.ⁱ Serious adverse reactions occurred in 35% of patients who received BRUKINSA in combination with obinutuzumab. Adverse reactions led to permanent discontinuation of BRUKINSA in 17% of patients.

Christopher Flowers, M.D., Division Head of Cancer Medicine and Chair of the Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center commented, “Patients living with follicular lymphoma often experience relapse or do not respond to treatment and need options for treatment during the course of their illness. The findings from the ROSEWOOD trial highlight the significant clinical advantage of treating patients who experience relapse or have refractory follicular lymphoma with zanubrutinib plus obinutuzumab.”

“Follicular lymphoma can significantly impact patients' lives and prove to be challenging, especially for those whose condition has advanced despite undergoing prior treatment or experienced relapse,” said the Follicular Lymphoma Foundation. “However, the emergence of new treatment options which have been shown to be effective and well-tolerated, including second generation BTK inhibitors such as zanubrutinib in combination with existing therapies, brings hope to those dealing with advanced follicular lymphoma.”

In addition to R/R FL, BRUKINSA is also approved in the U.S. as a treatment for adult patients with Waldenström’s macroglobulinemia; mantle cell lymphoma, who have received at least one prior therapy, R/R marginal zone lymphoma, who have received at least one anti-CD20-based regimen; and most recently chronic lymphocytic leukemia or small lymphocytic lymphoma. BRUKINSA is the first and only BTK inhibitor to demonstrate PFS superiority in a head-to-head clinical trial versus ibrutinib in patients with R/R CLL in the global Phase 3 ALPINE trial. In a recent presentation, BRUKINSA showed sustained PFS benefit versus ibrutinib in a longer term follow up. Durable PFS was observed across major subgroups, including in the high-risk 17p deletion/TP53 mutated patient population.

BRUKINSA is approved in 70 markets, including the U.S., EU, Great Britain, Canada, Australia, China, South Korea and Switzerland in selected indications, and it is under development for additional indications globally. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.