BeiGene to seek accelerated US approval of zanubrutinib; new data on PD-1 antibody

China’s BeiGene (Nasdaq: BGNE) says that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the US Food and Drug Administration for the treatment of patients with Waldenström macroglobulinemia (WM).

Based on BeiGene’s discussions with the FDA, internal review of available data from its global Phase I trial of zanubrutinib in patients with WM, and supported by the Fast Track designation, BeiGene is preparing to submit in the first half of 2019 a New Drug Application (NDA) to pursue an accelerated approval of zanubrutinib for patients with WM based on results from the global Phase I study. A final determination to submit the NDA will be made subsequent to the pre-NDA meeting with FDA after obtaining mature data from the study this fall.

“We believe zanubrutinib is a differentiated BTK inhibitor based on the depth and durability of responses observed in our ongoing global Phase I trial of zanubrutinib in WM patients. We look forward to working closely with the FDA in the continuing development of zanubrutinib for the treatment of this disease,” commented John Oyler, co-founder, chief executive and chairman of BeiGene. “We are hopeful that zanubrutinib, if approved, may represent a valuable and important treatment option for patients with WM.”