Citius Pharmaceuticals receives Complete Response Letter from FDA for LYMPHIR

Citius Pharmaceuticals announced that the U.S. Food and Drug Administration, or FDA, has issued a Complete Response Letter regarding the company’s Biologics License Application seeking approval for denileukin diftitox, 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. The FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review. Importantly, there were no concerns relating to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.