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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Cutaneous T-cell Lymphoma |
| Drug: | Ontak (denileukin diftitox) (IL-2 stimulant) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
ANTICANCER AGENT “Remitoro® INTRAVENOUS DRIP INFUSION 300µg”(DENILEUKIN DIFTITOX (GENETIC RECOMBINANT)) APPROVED IN JAPAN FOR PERIPHERAL T-CELL LYMPHOMA AND CUTANEOUS T-CELL LYMPHOMA
Published date:
03/23/2021
Excerpt:
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has obtained manufacturing and marketing approval for the anticancer agent “Remitoro® for Intravenous Drip Infusion 300μg” (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.
Source:
Title:
Citius Pharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submission
Published date:
04/06/2022
Excerpt:
Citius Pharmaceuticals, Inc...reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK®, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.
Trial ID:
