CDSCO gives approval for Tremelimumab combination in India

The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India.

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CDSCO Central Drug Standard Control Organisation
CDSCO

Last Updated on December 31, 2023 by The Health Master

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its cancer drug Tremelimumab Concentrate to be administered intravenously.

The approval for Tremelimumab in combination with Durvalumab is based on results from Phase III HIMALAYA clinical trial and is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC).

The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India.

This approval paves way for the launch of Tremelimumab solution of 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single dose vials) in India for the specified indication.

The common causes and risk factors for HCC in India include- cirrhosis, hepatitis B infection, hepatitis C infection, alcohol, smoking, diabetes, NAFLD (Non-Alcoholic Fatty Liver Disease).

The five-year survival rate for HCC is about 18 per cent; localised, regional and metastatic HCC have a 5-year overall survival (OS) of 33 per cent, 10 per cent and 2 per cent respectively.

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