China NMPA accepts BeiGene’s sNDA for Brukinsa to treat CLL and grants breakthrough therapy designation
BeiGene, a global, science-driven biotechnology company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) as a treatment for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and granted Brukinsa breakthrough therapy designation (BTD).
“This is Brukinsa’s first filing in treatment-naïve CLL supported by the positive global phase 3 SEQUOIA trial, a remarkable step forward in its global registration program. As presented at ASH, Brukinsa significantly prolonged progression-free survival and was generally well-tolerated in these patients, with demonstrated superiority over chemoimmunotherapy in the SEQUOIA trial,” commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “Together with the filing in Waldenström’s macroglobulinemia, we are hoping to expand the clinical use of this potential best-in-class BTK inhibitor from relapsed or refractory setting to frontline care for the blood cancer community in China.”
The sNDA is supported by clinical results from the randomized, multicenter, global Phase 3 SEQUOIA trial (NCT03336333) comparing Brukinsa to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL.
As assessed by an independent review committee (IRC), Brukinsa demonstrated superiority in progression-free survival (PFS) over B+R. With a median follow-up of 26.15 months, the 24-month PFS was 85.5% (95% CI: 80.1, 89.6) with Brukinsa, compared to 69.5% (95% CI: 62.4, 75.5) with B+R, and the hazard ratio (HR) was 0.42 (95% CI: 0.27, 0.63), p<0.0001. BRUKINSA was generally well tolerated with a safety profile consistent with its broad clinical program, including a low rate of atrial fibrillation.
Chronic lymphocytic leukaemia (CLL) is the most common form of leukaemia in adults, with a global incidence of approximately 114,000 new cases in 2017. CLL affects white blood cells or lymphocytes in the bone marrow, Proliferation of cancer cells (leukaemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.1,2,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.4 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.
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.
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.
Monday, January 31, 2022
