The US Food and Drug Administration has approved Citius Pharmaceuticals’ blood cancer therapy, Lymphir, for relapsed patients who have received at least one prior treatment, the company said on Thursday.
The approval comes after the health regulator initially declined to approve the therapy last year, seeking additional product testing data.
Lymphir, Citius’ first approved treatment, is expected to launch within the next five months and is approved for certain adult patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin.
The cancer has an incidence rate of 8.55 in one million people in the United States, according to government data.
The FDA’s approval is based on data from a late-stage trial, which showed that 36.2 per cent of patients treated with Lymphir showed partial or complete response to the treatment while reducing skin disease in 84 per cent of patients in the study.
Citius acquired the licensing rights to Lymphir from India’s Dr Reddy’s Laboratories for an upfront payment of $40 million. Dr Reddy’s is also entitled to an additional $40 million in milestone payments related to US approval of the therapy.