Aug 6 (Reuters) - The U.S. Food and Drug Administration
has approved Citius Pharmaceuticals' ( CTXR ) 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 1 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% of patients treated with Lymphir showed
partial or complete response to the treatment while reducing
skin disease in 84% 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 U.S. approval of the therapy.