News from the FDA/CDC

FDA Approves Lymphir for R/R Cutaneous T-Cell Lymphoma


 

The Food and Drug Administration has approved denileukin diftitox-cxdl (Lymphir, Citius Pharmaceuticals) for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after at least one prior systemic therapy.

The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021.

This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.

This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.”

Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.

The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus.

Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.

The company expects to launch the agent within 5 months.

A version of this article first appeared on Medscape.com.

Recommended Reading

The ASCO Annual Meeting Starts This Week
MDedge Dermatology
Doctors Endorsing Products on X May Not Disclose Company Ties
MDedge Dermatology
Oncology Mergers Are on the Rise. How Can Independent Practices Survive?
MDedge Dermatology
Neurofilament Light Chain Detects Early Chemotherapy-Related Neurotoxicity
MDedge Dermatology
Cancer Drug Shortages Continue in the US, Survey Finds
MDedge Dermatology
Time Warp: Fax Machines Still Common in Oncology Practice. Why?
MDedge Dermatology
Weight Loss Drugs Cut Cancer Risk in Diabetes Patients
MDedge Dermatology
Greater Transparency of Oncologists’ Pharma Relationships Needed
MDedge Dermatology
Ancient Viruses in Our DNA Hold Clues to Cancer Treatment
MDedge Dermatology
Immunotherapy May Be Overused in Dying Patients With Cancer
MDedge Dermatology