US FDA approves Citius’ blood cancer therapy, Health News, ET HealthWorld

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US FDA approves Citius’ blood ******* therapy, Health News, ET HealthWorld

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London: The U.S. Food and ***** Administration has approved Citius Pharmaceuticals’ blood ******* 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 ****** patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin.

The ******* has an incidence rate of 8.55 in 1 million people in the ******* 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 ******** 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. (Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Tasim Zahid)

• Published On Aug 8, 2024 at 05:38 PM IST

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