FDA Approves Citius Pharmaceuticals’ Lymphir for Cutaneous T-Cell Lymphoma

Citius Pharmaceuticals announced yesterday that FDA has granted approval for Lymphir, a treatment for adults with relapsed or refractory Cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.

In yesterday’s announcement, Citius shared Lymphir is the first and only CTCL therapy specifically targeting the interleukin-2 (IL-2) receptor found on malignant T-cells and regulatory T-cells (Tregs). The drug is also the first FDA-approved product for Citius.

In an email to MHE, a Citius spokesperson said Lymphir is expected to launch within the next five months with pricing expected to be “in line” with other systematic therapies for CTCL, including chemotherapy, oral retinoids, biologic therapies or inhibitors.

Based on a study published in the British Journal of Dermatology in 2020, CTCL was estimated to cost $73,389 in the average patient's lifetime and $2.84 billion to the U.S. healthcare system.

The Cituis spokesperson added that they “do not anticipate an issue with reimbursement” when asked how it will affect insurance coverage for patients.

CTCL is a rare type of cutaneous non-Hodgkin lymphoma (NHL), approximately affecting 2,500 to 3,000 patients who are diagnosed each year. It’s also more prevalent in men, with most cases diagnosed between the ages of 50 and 60.

In CTCL, T-cells — essential components of the immune system — become cancerous, leading to red, scaly patches on the skin.

Although it’s typically a slow-growing cancer, CTCL can still be critical, especially when it spreads to lymph nodes and internal organs.

For patients with CTCL, treatment options have been limited, often forcing them to cycle through several skin-directed therapies before the cancer becomes resistant or progressive, according to a news release from Citius.

Myron Czuczman, chief medical officer of Citius Pharmaceuticals, said his team believe the drug’s receptor-targeted treatment will stand out and offer meaningful benefits to a significant percentage of CTCL patients.

“As the only IL-2 receptor-targeted immunotherapy for CTCL, LYMPHIR provides a novel and non-cross-resistant treatment option without cumulative toxicity for Stage I-III r/r patients for whom symptomatic skin involvement interferes with their daily quality of life,” Czuczman said in the release.

The median time-to-response for Lymphir is just 1.4 months, offering patients rapid relief from skin symptoms.

Francine Foss, professor of Hematology and director of the Multidisciplinary T-cell Lymphoma Program at Yale Cancer Center, emphasized the significance of the therapy.

“As a treating oncologist, I have seen the profound negative effect on the quality of life in patients with r/r CTCL,” Foss said. “Given the long-term nature of the disease, pruritus, ulceration of the tumors, and secondary pyogenic skin infection, it is vital to get this skin involvement under control. LYMPHIR is the first therapeutic option in many years to offer hope of reducing skin disease, bringing us one step closer to filling the need for CTCL patients, particularly those that are not able to complete or continue prior therapies."

The FDA's approval of Lymphir is based on results from a Phase 3 Study which involved CTCL patients who had previously received at least one systemic treatment.

The study showed that the objective response rate (ORR) was 36.2%, with 8.7% of patients achieving a complete response.

Most participants (around 70%) saw results after just one or two cycles of treatment, and the duration of responses lasted at least six months for over half of the patients.

Leonard Mazur, CEO of Citius, expressed his optimism in the release about the impact of the therapy, expecting it to grow the overall market, currently estimated at $300-$400 million.