New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has authorised AstraZeneca Pharma India’s Tremelimumab Concentrate for intravenous administration, the firm announced on Thursday.
Tremelimumab in combination with Durvalumab has been approved for the treatment of patients with unresectable hepatocellular carcinoma (uHCC), the most common kind of primary liver cancer, based on the results of a Phase III clinical trial.
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The research, which was done in 16 countries including India, the United States, and Canada, revealed a good and significant benefit for overall survival for the combination of Tremelimumab and Durvalumab against Sorafenib, according to the company in a statement.
The approval allows Tremelimumab solution 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single dose vials) to be launched in India for the stated indication.
“The prognosis of patients with unresectable liver cancer is frequently limited, and diagnosis is often delayed, with the majority of cases being diagnosed in an advanced and unresectable stage.” As a result, novel therapy options for enhancing long-term survival become critical,” said Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, in a statement.
The Phase III trial compared sorafenib, a standard-of-care multi-kinase inhibitor, to a regimen consisting of a single priming dose of Tremelimumab 300 mg coupled to Durvalumab 1500 mg followed by Durvalumab every four weeks.
The trial enrolled 1,324 patients with unresectable, advanced HCC who had not previously received systemic therapy and were not candidates for locoregional therapy (treatment limited to the liver and surrounding tissue).
According to Globocan India 2020, around 30,000 new local instances of hepatocellular carcinoma (HCC) are detected each year, making it India’s tenth most prevalent cause of cancer. Because of its high mortality rate, it is the eighth leading cause of cancer-related fatalities in the United States.
Cirrhosis, hepatitis B and C infection, alcohol, smoking, diabetes, and non-alcoholic fatty liver disease are significant causes and risk factors for HCC in India. HCC has a 5-year survival rate of roughly 18%; localised, regional, and metastatic HCC had 5-year overall survival rates of 33%, 10%, and 2%, respectively.
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