Citius Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Lymphir (denileukin diftitox-cxdl) to treat relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL).
Lymphir, a novel immunotherapy, is now approved in the US for the treatment of CTCL patients following at least one prior systemic therapy.
The approval marks the first indication for Lymphir and represents Citius Pharma’s inaugural FDA-approved product.
In 2021, denileukin diftitox was approved in Japan for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
Later that year, Citius Pharmaceuticals acquired a license from Dr Reddy’s Laboratories to develop and commercialise Lymphir in all markets except Japan and certain regions in Asia.
Citius Pharmaceuticals CEO Leonard Mazur said: “Lymphir offers new hope for patients suffering from cutaneous T-cell lymphoma, a rare and chronic cancer characterised by debilitating skin lesions and severe itching.
“This approval is a significant milestone for CTCL patients. The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the CTCL treatment landscape and grow the overall market, currently estimated to be $300-$400m.”
The approval of Lymphir is based on data from Phase 3 Study 302 in which the primary efficacy analysis included 69 patients with stage 1-3 CTCL who were administered denileukin diftitox-cxdl.
The main efficacy measure was Objective Response Rate (ORR), as evaluated by an Independent Review Committee (IRC).
According to the results, the ORR was 36.2%, with 8.7% achieving a Complete Response (CR).
The median time to response was notably quick, at 1.41 months, with approximately 70% of responders seeing results after a couple of cycles of treatment.
Among the 64 skin-evaluable subjects, 84.4% experienced a reduction in skin tumour burden, and 12.5% achieved complete clearance of skin disease.
Additionally, pruritus, assessed as an exploratory endpoint, showed clinically significant improvement in 31.7% of patients.
Furthermore, the safety profile of Lymphir aligns with its known safety profile.
The drugmaker’s late-stage pipeline also features Mino-Lok, an antibiotic lock solution and CITI-002 (Halo-Lido), a topical formulation.
The latest approval comes after Citius Pharmaceuticals agreed to a business combination of its oncology subsidiary with TenX Keane Acquisition.
