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A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

Trial Profile

A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2024

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At a glance

  • Drugs Denileukin diftitox (Primary)
  • Indications Cutaneous T-cell lymphoma; Mycosis fungoides; Sezary syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Eisai Inc
  • Most Recent Events

    • 18 Mar 2024 According to a Citius Pharmaceuticals Inc media release, U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.
    • 13 Feb 2024 According to a Citius Pharmaceuticals Inc media release, company has announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR. FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission.
    • 08 Sep 2023 According to a Citius Pharmaceuticals Inc media release, The FDA has agreed with the Company's plans to address the requirements outlined in the complete response letter (CRL) received July 28, 2023.
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