Eisai Launches Remitoro (Denileukin Diftitox) in Japan for Relapsed or Refractory Peripheral and Cutaneous T-Cell Lymphomas

May 23, 2021 /BioValleyBIOON/ -- Japanese pharmaceutical company Eisai recently announced that it has launched in Japan the anticancer agent Remitoro Intravenous Infusion 300μg (denileukin diftitox [genetically recombinant]), indicated for the treatment of: relapsed or refractory peripheral T-cell lymphoma (PTCL) and relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Eisai Co., Ltd. obtained approval for the manufacturing and marketing of Remitoro in March 2021. According to a survey by Japan’s Ministry of Health, Labour and Welfare (MHLW), it is estimated that there are fewer than 6,000 patients with PTCL and fewer than 4,000 patients with CTCL in Japan. These diseases may carry a poor prognosis or be difficult to treat. Therefore, a high unmet medical need remains for these conditions.

The active pharmaceutical ingredient of Remitoro is denileukin diftitox (recombinant), a fusion protein of the interleukin-2 (IL-2) receptor-binding domain and diphtheria toxin, specifically binding toTumorIL-2 receptors on the surface of lymphocytes, followed by intracellular delivery and release of diphtheria toxin.

Anti-denileukin diftitoxTumorIts mechanism of action relies on the intracellular delivery of diphtheria toxin, which inhibits protein synthesis and induces cell death. Eisai retains exclusive development and commercialization rights for denileukin diftitox in Japan, Asia, and other regions.

Mechanism of Action of Denileukin Diftitox

In Japan, the approval of Remitoro was primarily based on data from a multicenter, open-label, single-arm Phase II clinical study (Study 205). The study was conducted in Japan and evaluated the efficacy and safety of denileukin diftitox in patients with relapsed or refractory CTCL or PTCL.

The results showed that the study met its primary endpoint and exceeded the prespecified threshold, demonstrating statistical significance: the objective response rate (ORR) in patients with CTCL and PTCL (n=36) was 36.1% (95% CI: 20.8–53.8). The ORR was 31.6% (95% CI: 12.6–56.6) in the CTCL group (n=19) and 41.2% (95% CI: 18.4–67.1) in the PTCL group (n=17).

In this study, the 5 most commonly observed`Adverse Reactions`Respectively: elevated aspartate aminotransferase (AST) (89.2%), elevated alanine aminotransferase (ALT) (86.5%), hypoproteinemia (70.3%), lymphopenia (70.3%), and fever (51.4%).

Eisai will conduct a post-marketing special use-results survey (all-case surveillance) for all patients receiving Remitoro treatment until the predetermined number of patients is reached in accordance with the approval conditions stipulated by the Japanese Ministry of Health, Labour and Welfare (MHLW). (Bioon.com)

Source: ANTICANCER AGENT “Remitoro INTRAVENOUS DRIP INFUSION 300μg” (DENILEUKIN DIFTITOX (GENETICAL RECOMBINATION)) LAUNCHED IN JAPAN FOR PERIPHERAL T-CELL LYMPHOMA AND CUTANEOUS T-CELL LYMPHOMA