Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
TOKYO, May 16, 2025 – (JCN Newswire via SeaPRwire.com) – Eisai Co., Ltd. announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the “all-case surveillance” post-marketing observational study condition required at the time of approval of anticancer agent “Remitoro® for Intravenous Drip Infusion 300μg” (Denileukin Diftitox (Genetical Recombination)) for the indications of T-cell Lymphoma has been cleared.In March 2021, the MHLW approved “Remitoro” with the indications of “relapsed or refractory PeripheralT- cell Lymphoma (PTCL)” and “relapsed or refractory Cutaneous T-cell Lymphoma (CTCL)” , in Japan, with the following condition: “Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients untildata from a certain number of patients is accumulated after its launch in the market, in order to identify thebackground information of patien…