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BLA Resubmitted to FDA for Denileukin Diftitox in Relapsed/Refractory Cutaneous T-cell Lymphoma

Denileukin Diftitox BLA Resubmitted for CTCL After Addressing FDA Concerns

The biologics license application for denileukin diftitox has been resubmitted to the FDA for the treatment of cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

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Anticancer Agent Remitoro Intravenous Drip Infusion 300 microgram (Denileukin Diftitox (Genetical Recombination)) Launched in Japan

For Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma Tokyo, May 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has launched the anticancer agent Remitoro® for Intravenous Drip Infusion 300µg (Denileukin Diftitox (Genetical Recombination)) with the indications of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL), in Japan. Eisai obtained the manufacturing and marketing approval of Remitoro on March 23, 2021. Remitoro was included to Japan s National Health Insurance Drug Price List on May 19, 2021. The agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin, and specifically binds to the IL-2 receptor on the surface of tumoral lymphocytes. The antitumor efficacy of denileukin diftitox is believed to depend on the intracellular delivery of diphtheria toxin fragment which inhibits protein synthesis and induce cell death.

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