US FDA approves Citius' therapy for rare blood cancer

[August 09, 2024]  By Mariam Sunny

(Reuters) -The U.S. Food and Drug Administration has approved Citius Pharmaceuticals' therapy for patients with a form of blood cancer who have received at least one prior treatment, the company said on Thursday, an year after the regulator rejected the treatment.

The therapy, called Lymphir, is approved to treat certain adult patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin. About 2,500-3,000 patients are diagnosed each year, the company estimated.

The company plans to launch the therapy in the next five months and said it would price it at comparable levels with existing treatments in the market.

The health regulator had declined to approve the therapy in July last year, and had sought additional product testing data.

The prescribing information for Lymphir carries the FDA's serious "boxed warning", flagging a life-threatening risk of a rare blood condition called capillary leak syndrome.

Capillary leak syndrome causes blood plasma to escape through tiny blood vessels and leads to a rapid drop in blood pressure.

Shares of the company were down 4.7% at 86 cents in morning trade.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

"We don't think (the warning) is going to pose a major problem for the patients or the physicians. They know what they have to be on alert for," CEO Leonard Mazur said.

The company plans to launch Lymphir through a separate unit, Citius Oncology, which is expected go public in the coming days through a SPAC deal, Mazur said.

Available treatments for patients include Bristol Myers Squibb's Istodax and Bausch Health's Targretin.

Citius acquired the licensing rights to Lymphir from India's Dr. Reddy's Labs in 2021.

(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)

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