Citius Pharma: FDA Issues CRL For LYMPHIRTM BLA For Patients With Cutaneous T-cell Lymphoma

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) announced that the U.S. Food and Drug Administration has issued complete response letter for Biologics License Application (BLA) seeking approval for denileukin diftitox (LYMPHIRTM), an engineered IL-2-diphtheria toxin fusion protein for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. There were no concerns relating to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.

The FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review.

The company intends to provide additional data and remains fully engaged with the FDA as it continues to work toward approval.

"We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make a meaningful difference in their lives," stated Leonard Mazur, Chairman and CEO of Citius.