Listen to this articleCitius Oncology Inc. has commercially launched Lymphir, a treatment for Stage I–III cutaneous T-cell lymphoma, the Cranford-based firm announced Dec. 1.
In August 2024, the U.S. Food and Drug Administration approved the medication – denileukin diftitox-cxdl – for adults with the rare form of non-Hodgkin lymphoma.
That same month, Citius Pharmaceuticals finalized the merger of its wholly owned oncology subsidiary with New York-based TenX Keane Acquisition. The result of the $675 million deal was Citius Oncology.
“LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology,” Leonard Mazur, chairman and CEO of Citius Oncology and Citius Pharmaceuticals, said in a statement.
“With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease,” Mazur added.
Lymphir marks Citius Oncology’s first marketed product. It is now available in the U.S. through specialty distributors.
$400M market
“We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future,” Mazur added.
Outside the U.S., Citius Oncology holds exclusive rights to develop and commercialize Lymphir in all global markets except India, Japan and parts of Asia. A new distribution agreement with Integris Pharma SA will initiate named-patient access programs in Greece, Cyprus and other Southern European and Balkan countries, Citius noted.
Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it,” Mazur added.
According to an Oct. 23 filing with the U.S. Securities and Exchange Commission, Citius Oncology has invested $90 million in Lymphir to date.
