The US Food and Drug Administration (FDA) has issued additional guidance to Citius Pharmaceuticals on the resubmission of a biologics license application (BLA) for Lymphir (denileukin diftitox) to treat cutaneous T-cell lymphoma (CTCL).
An engineered interleukin-2 (IL-2)-diphtheria toxin fusion protein, Lymphir is intended for relapsed or refractory CTCL patients following treatment with a minimum of one systemic therapy previously.
As per the new guidance, the regulator has agreed with Citius’ plans to meet the conditions provided in a complete response letter (CRL) issued on 28 July 2023.
The guidance also offers the company a roadmap for concluding the necessary steps to support the BLA resubmission for denileukin diftitox.
For the planned resubmission anticipated to occur in early 2024, the FDA has sought no further clinical efficacy or safety trials.
Citius Pharmaceuticals chairman and CEO Leonard Mazur said: “We are encouraged by the constructive engagement with the FDA.
“Based on the clear feedback from the FDA, Citius plans to complete the CRL remediation activities by the end of the year and file the resubmission in early 2024.
“We do not expect these efforts will impact our cash runway.”
The US regulator granted orphan drug designation to Lymphir to treat peripheral T-cell lymphoma (PTCL) and CTCL in 2011 and 2013, respectively.
The treatment obtained regulatory approval in Japan for these two indications in 2021.