BASEL, Switzerland, BEIJING, China & CAMBRIDGE, Mass. — BeiGene Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S.
“This accelerated approval of BRUKINSA represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the U.S. who have either not responded to initial therapies or have experienced relapse,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “BRUKINSA is the only BTK inhibitor to date that shows efficacy with this type of malignancy and now has the broadest label, including five oncology indications, of any medication in its class globally. This is a testament to BRUKINSA’s differentiated clinical profile and our continued commitment to bringing this much-needed treatment option to patients around the world.”
BRUKINSA was approved for the treatment of R/R FL under the FDA’s accelerated approval program based on the overall response rate (ORR) from the ROSEWOOD trial (NCT03332017), as assessed by an independent review committee (IRC). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY (NCT05100862) trial, which is underway. The application for R/R FL was also granted Fast Track Designation and Orphan Drug Designation by the FDA.
The ROSEWOOD trial is a global, randomized, open-label Phase 2 study of BRUKINSA plus obinutuzumab compared with obinutuzumab alone in 217 patients with R/R FL who received at least two prior lines of systemic therapy. In the study, the ORR by IRC was 69% in the BRUKINSA plus obinutuzumab arm versus 46% in the obinutuzumab arm (P=0.0012), with a median follow-up of approximately 20 months. Responses were durable, with an 18-month landmark duration of response (DOR) of 69% in the BRUKINSA combination arm.
BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines. 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.
About Follicular Lymphoma
Follicular lymphoma (FL) is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22% of all NHL cases.ii Approximately 15,000 cases are diagnosed in the U.S. each year.iii While FL remains incurable, people with the condition can live a long time. The five-year survival rate is about 90%, and approximately half of people diagnosed with FL can live with the disease for nearly 20 years.iv
About BRUKINSA® (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S.
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