Supplemental NDA accepted for leukaemia treatment in China

pharmafile | January 28, 2022 | News story | Medical Communications  

BeiGene, focused on developing innovative and affordable medicines, 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 their BTK inhibitor, BRUKINSA (zanubrutinib). This is a treatment for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphomatic lymphoma (SLL).

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.

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 programme as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA has received 20 approvals covering 43 different countries and regions.

“This is BRUKINSA’s first filing in treatment-naïve CLL supported by the positive global Phase III 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, MD, 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.”

Lina Adams

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