The US Food and Drug Administration has given the green light to Citius Pharmaceuticals' blood cancer therapy, Lymphir, for patients who have relapsed after at least one prior treatment, according to a company announcement on Thursday.
This approval follows the health regulator's previous decision not to approve the therapy last year, due to a request for additional product testing data. Lymphir, which marks Citius' first approved treatment, is slated to hit the market within the next five months and is intended for adult patients with relapsed cutaneous T-cell lymphoma, a rare group of blood cancers affecting the skin. Government data indicates that the incidence rate of this cancer is 8.55 per one million people in the United States.
The FDA's decision is supported by data from a late-stage trial, revealing that 36.2 percent of patients treated with Lymphir experienced either a partial or complete response to the treatment, with skin disease reduction observed in 84 percent of the study's participants. Citius secured the licensing rights to Lymphir from India's Dr Reddy's Laboratories for an initial payment of $40 million, with Dr Reddy's eligible for an additional $40 million in milestone payments tied to the therapy's US approval.
