New medicine for T cell lymphoma!

Japanese pharmaceutical company Eisai (Eisai) recently announced that it has launched an anticancer drug Remitoro 300μg (denileukin diftitox [gene recombination]) intravenously in Japan, the drug is used to treat: relapsed or refractory peripheral T-cell lymphoma (PTCL) , Relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Eisai obtained Remitoro's production and sales license in March 2021.

Remitoro's active pharmaceutical ingredient denileukin diftitox (gene recombination), which is a fusion protein of interleukin-2 (IL-2) receptor binding site and diphtheria toxin, which specifically binds to the IL-2 receptor on the surface of tumor lymphocytes.

The anti-tumor effect of denileukin diftitox depends on the intracellular delivery of diphtheria toxin, which can inhibit protein synthesis and induce cell death.

In Japan, Remitoro's approval is mainly based on data from a multi-center, open-label, single-arm Phase II clinical study (Study 205).

The results showed that the study reached the primary endpoint and exceeded the predetermined threshold, which was statistically significant: the objective response rate (ORR) of CTCL patients and PTCL patients (n=36) was 36.

In the study, the five most common adverse reactions observed were: elevated aspartate aminotransferase (AST) (89.

Eisai will conduct a post-marketing special use results survey (monitoring of all cases) on all patients treated with Remitoro until the predetermined number of patients is reached according to the approval conditions set by the Ministry of Health, Labour and Welfare (MHLW) of Japan.

Original 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