HONG KONG – Daiichi Sankyo Co. Ltd. has won regulatory approval for Enhertu (trastuzumab deruxtecan) in Japan based on a pivotal phase II trial alone. The HER2-directed antibody-drug conjugate has been approved for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd., a subsidiary of Roche Holding AG, has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) to add new indication to the list of those treatable with its combination of Tecentriq (atezolizumab) and Avastin (bevacizumab): unresectable hepatocellular carcinoma (HCC). Both medicines originated at Genentech Inc.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Algernon, Apeiron, Bridge, Cipla, Covaxx, Dr. Reddy’s, Durect, Eiger, Enterome, Immunic, Innovent, Johnson & Johnson, Novavax, Oncimmune, Pulmatrix, Sinovac, Takeda, Viralclear.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Allovir, Ampio, Arca, AVM, Celltrion, Eisai, Epimab, Equillium, Harbour Biomed, Hutchison China Meditech, I-Mab, Junshi, Mateon, Morphosys, Sorrento, Takeda.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: 3D Medicines, Aim Immunotech, Algernon, Alphamab Oncology, Aslan, Astellas, Astrazeneca, Atossa, Atyr, Beigene, Clinuvel, Direct Biologics, Eli Lilly, Galera, Kyorin, Leap, Onconova, Opko Health, Rigel, Roche, Tracon.
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