BeiGene's Btk inhibitor gets U.S. breakthrough designation

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said FDA granted breakthrough therapy designation to zanubrutinib (BGB-3111) to treat second-line mantle cell lymphoma (MCL). BeiGene President and General Manager of China Xiaobing Wu told BioCentury zanubrutinib is the first cancer therapy from mainland China to receive the designation in the U.S.

Wu said the Bruton's tyrosine kinase (Btk) inhibitor was designed with target selectivity and oral bioavailability advantages over approved Btk inhibitor Imbruvica ibrutinib, which could lead to improved tolerability and efficacy. AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) market Imbruvica to treat MCL, as well as several other blood cancers and graft-versus-host disease (GvHD)...