FDA approves Citius’ Lymphir Therapy for rare blood cancer

The U.S. Food and Drug Administration (FDA) has given the green light to Citius Pharmaceuticals’ new therapy, Lymphir, for treating a rare form of blood cancer known as cutaneous T-cell lymphoma. This approval comes a year after the FDA initially rejected the treatment.

Key Details

  • Treatment Overview
    • Name: Lymphir
    • Type: Therapy for cutaneous T-cell lymphoma
    • Target Patients: Adults with relapsed cutaneous T-cell lymphoma who have received at least one prior treatment
    • Prevalence: About 2,500 to 3,000 new cases annually in the U.S.
  • Approval and Launch
    • Initial Rejection: July of the previous year due to a need for additional testing data
    • Launch Timeline: Planned within the next five months
    • Pricing: Expected to be in line with existing market treatments
  • Safety Concerns
    • Boxed Warning: The FDA’s prescribing information includes a serious warning for capillary leak syndrome, a rare condition that causes blood plasma to leak from small blood vessels and results in a rapid drop in blood pressure.
  • Market Context
    • Existing Treatments: Includes Bristol Myers Squibb’s Istodax and Bausch Health’s Targretin
    • Company’s Response: CEO Leonard Mazur expressed confidence that the boxed warning will not significantly hinder the therapy’s adoption, as both patients and physicians are aware of the risks.
  • Company Plans
    • New Launch Unit: Lymphir will be introduced through Citius Oncology, which is set to go public soon through a SPAC deal.