Remitoro, intravenous drip infusion is approved in Japan for peripheral T-cell lymphoma and cutaneous T-cell lymphoma. Eisai .

Eisai Co., Ltd.announced that it has obtained manufacturing and marketing approval for the anticancer agent Remitoro for Intravenous Drip Infusion 300 ug(denileukin diftitox (genetic recombinant)) with the indications of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL), in Japan. This agent was evaluated by the Ministry of Health, Labour and Welfare (MHLW) as a drug with high medical need at the “Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Need”. Hence, Eisai has been working on the development of the agent thereof in Japan, and applied for manufacturing and marketing approval in March 2020, based primarily on data from a Phase II clinical study (Study 205). Study 205 is a multicenter, open-label, single-arm Phase II clinical study, conducted in Japan to evaluate the efficacy and safety of the agent in patients with relapsed or refractory PTCL or CTCL. This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: the objective response rate (ORR) of PTCL and CTCL patients in total (n=36) was 36.1% (95% confidence interval (CI): 20.8-53.8). The ORRs of each subtype were 41.2% (95%CI: 18.4-67.1) for PTCL (n=17) and 31.6% (95% CI: 12.6-56.6) for CTCL (n=19). The five most frequent treatment-emergent adverse events observed in this study were increased aspartateamino transferase (AST) (89.2%), increased alanine aminotransferase (ALT) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%). Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered the agent until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW.