AstraZeneca's Liver Cancer Drug Approved by CDSCO in India

The CDSCO has approved the intravenous administration of AstraZeneca Pharma India's liver cancer drug, Tremelimumab Concentrate.

AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved its liver cancer drug, Tremelimumab Concentrate, for intravenous administration.

Tremelimumab and Durvalumab are two medications that have been combined and tested together in a Phase III clinical trial. Based on the results of this trial, the regulatory authorities have given their approval for the use of Tremelimumab in combination with Durvalumab as a treatment option for patients with uHCC, unresectable hepatocellular carcinoma (uHCC) - the most common type of primary liver cancer ().

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‘This treatment plan included giving patients a single priming dose of Tremelimumab, at a strength of 300 mg. They also gave them Durvalumab, at a strength of 1500 mg. This priming dose was followed by regular doses of Durvalumab given every four weeks. #Liver Cancer #Cancer Drug’

The trial, conducted across 16 countries, including India, the US and Canada, showed a positive and significant benefit for overall survival for the combination of Tremelimumab and Durvalumab versus Sorafenib, the company said, in a statement.

The 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, it added.

"Prognosis of patients with unresectable liver cancer is often limited and diagnosis is significantly delayed, with the majority of the cases getting diagnosed in an advanced and unresectable stage. Hence, novel treatment alternatives become paramount for improving long-term survival," said Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, in the statement.

Trial Involved 1,324 Patients with Advanced, Unresectable HCC

The Phase III trial included a regimen comprising a single priming dose of Tremelimumab 300 mg added to Durvalumab 1500 mg followed by Durvalumab every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.

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The trial included a total of 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localised to the liver and surrounding tissue).

Globocan India 2020 reports more than 30,000 new local cases of hepatocellular carcinoma (HCC) are diagnosed every year, making it the 10th most common cause of cancer in India. Its high mortality rate makes it the eighth most common cause of cancer related deaths in the country.

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The common causes and risk factors for HCC in India include cirrhosis, hepatitis B and C infection, alcohol, smoking, diabetes, and non-alcoholic fatty liver disease.

The 5-year survival rate for HCC is about 18 percent; localised, regional and metastatic HCC have a 5-year overall survival of 33 percent, 10 percent and 2 percent respectively.

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Reference:

Systemic treatment for unresectable hepatocellular carcinoma - (https://pubmed.ncbi.nlm.nih.gov/36970588/)

Source-IANS