Takeda to seek Japan approval for gastric cancer drug next year

Takeda plans to seek regulatory approval in Japan next year for arcotatug tavatecan (TAK-921), a late-stage gastric cancer drug after a study showed benefits for advanced gastric or gastroesophageal junction cancer patients. At the European Society for Medical Oncology meeting in Madrid, PK Morrow said Takeda will file a new drug application (NDA) in Japan using the data. In the 464-patient trial, median overall survival was 10.2 months with the drug versus 6.9 months with physician’s choice chemotherapy, and median progression-free survival was 7.1 months versus 3.1 months. Serious side effects occurred in about 47% versus 56%.