Feb. 22 Quick Takes: Enhertu meets mark in breast cancer subgroup
Plus updates from BeiGene, Takeda, Code, Kiniksa, Hangzhou, Homology and more
AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Daiichi Sankyo Co. Ltd. (Tokyo:4568) said antibody-drug conjugate Enhertu fam-trastuzumab deruxtecan-nxki led to progression-free and overall survival benefits in the HER2-low population of metastatic breast cancer patients surveyed in the Phase III DESTINY-Breast04 trial. The HER2-targeted drug is approved to treat HER2-positive breast cancer and gastric cancer.
BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160; Shanghai:688235) said FDA is reviewing Btk inhibitor Brukinsa zanubrutinib to treat chronic lymphocytic leukemia or small lymphocytic leukemia, with a PDUFA date of Oct. 22. The biotech said EMA has also accepted for review its regulatory applications for Brukinsa to treat CLL and marginal zone lymphoma. The drug is approved in the U.S. to treat mantle cell lymphoma, Waldenström’s macroglobulinemia and MZL; and in the EU to treat Waldenström’s...