CAMBRIDGE, Mass. and BEIJING– BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common form of adult leukemia. The Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022.
“We are pleased with the FDA’s acceptance of BRUKINSA’s filing in CLL. This is an important milestone in BRUKINSA’s global registration program. With superiority in investigator-assessed ORR over ibrutinib in ALPINE for relapsed or refractory patients and in PFS over chemoimmunotherapy in the SEQUOIA study for treatment-naïve patients, BRUKINSA has demonstrated its potential to improve treatment outcomes for CLL patients,” commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “We look forward to furthering our discussions with the FDA on this filing and the potential to bring this important treatment option to the CLL community in the U.S.”
The sNDA filing in CLL/SLL includes data from two pivotal randomized Phase 3 studies and eight supportive studies in B cell malignancies. The two global Phase 3 trials of BRUKINSA in CLL/SLL are: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients and SEQUOIA (NCT03336333) comparing BRUKINSA to bendamustine and rituximab in treatment-naïve (TN) patients. Additionally, the SEQUOIA study enrolled patients with deletion 17p in a non-randomized arm evaluating BRUKINSA monotherapy in this high risk population. ALPINE and SEQUOIA enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand and multiple countries in Europe. Results from the ALPINE trial and the SEQUOIA trial were reported at the 26th European Hematology Association (EHA2021) Virtual Congress in June 2021 and at the 63rd American Society for Hematology (ASH) Annual Meeting in December 2021, respectively.
“While previously approved BTK inhibitors have been transformational for some patients with CLL, there continues to be unmet need as not all patients achieve a favorable clinical response while others are unable to tolerate currently approved BTKi therapies,” said Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, and a principal investigator in the two studies. “As demonstrated in both the ALPINE AND SEQUOIA studies, BRUKINSA was generally well-tolerated in CLL patients with low rates of atrial fibrillation and showed strong efficacy compared to ibrutinib and chemoimmunotherapy, respectively.”
