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US FDA approves Citius' blood cancer therapy
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US FDA approves Citius' blood cancer therapy
Aug 8, 2024 4:27 AM

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.

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