The FDA has just approved the new treatment from Citius Pharmaceuticals, Lymphir, for certain patients with blood cancer who have at least one prior treatment. The FDA approved Lymphir to treat a very rare and highly difficult-to-cure kind of blood cancer, relapsed cutaneous T-cell lymphoma, which normally affects the skin area. According to Citius Pharmaceuticals, CTCL is diagnosed in some 2,500-3,000 new cases in the United States annually.

The greenlight for Lymphir represents a major win for Citius Pharmaceuticals, particularly after the FDA rejected the treatment in July last year, for lack of sufficient product testing data. Lymphir is expected to launch within five months. The pricing will be competitive with already established products on the market.

Lymphir is a gene-encoding, targeted immune therapy for the treatment of patients with R/R CTCL, with Stage I-III disease, who have previously received at least one prior systemic therapy. The treatment binds to IL-2 receptors and inhibits protein synthesis by including fragments of diphtheria toxin, inducing apoptosis in IL-2 receptor-expressing tumors. The cytocidal action of Lymphir, depleting immunosuppressive Tregs, supplements its antitumor activity.

The FDA, however, has put a “boxed warning” on Lymphir, citing a potentially life-threatening risk of capillary leak syndrome—a condition in which blood plasma oozes out through tiny blood vessels, leading to rapid blood pressure fall. While this warning is serious, the approval of Lymphir offers new hope for an effective treatment option for patients with CTCL relapse and possibly improved outcomes for a disease that is so difficult to treat.

This is a huge success for Citius Pharmaceuticals after earlier gaining approval in 2021 for Lymphir in Japan for the treatment of CTCL and PTCL. Citius Pharmaceuticals secured the exclusive worldwide rights to develop and commercialize this therapy, excluding Japan and parts of Asia.

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