Citius Pharma receives FDA approval for LYMPHIR (denileukin diftitox-cxdl) in r/r CTCL

Citius Pharmaceuticals, Inc.

Phase 3 study showed 36.2% ORR, 8.7% complete response, median time to response 1.41 months.
First FDA-approved product for Citius; launch expected within next five months.
Boxed warning for capillary leak syndrome; postmarketing requirement to assess visual impairment risk.
Only systemic therapy targeting IL-2 receptor on malignant T-cells and Tregs for CTCL.
US market for r/r CTCL estimated at $300–$400 million; no cumulative toxicity observed.

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