FDA approval announcements and Citius Pharmaceuticals' press releases

Citius Pharmaceuticals Gains FDA Approval for Lymphir with Boxed Warning

Aug 8, 2024, 01:30 PM

Citius Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for its blood cancer therapy, Lymphir (denileukin diftitox-cxdl), aimed at treating adults with relapsed or refractory cutaneous T-cell lymphoma. This approval marks a significant milestone for Citius as it secures its first FDA approval. Lymphir is designed for patients who have undergone at least one prior treatment. The FDA's decision includes a boxed warning, highlighting potential risks associated with the therapy. The approval is expected to provide a new therapeutic option for patients with limited treatment choices.