Posted by Michael Wonder on 30 Jul 2023
Citius Pharmaceuticals receives a complete response letter from the US FDA for Lymphir (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma
29 July 2023 - No clinical efficacy or safety issues raised.
Citius Pharmaceuticals today announced that the US FDA has issued a complete response letter regarding the Company's biologics license application seeking approval for denileukin diftitox (Lymphir), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy.
