AstraZeneca receives CDSCO approval for Tremelimumab combination in India 

Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) 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 the 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 the 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. Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said, “As pioneers in science, we are united in our aim of improving the lives of patients. This approval is in line with our ambition of transforming patient outcomes and not leaving any patient behind. We have a breadth of scientific platforms to attack cancer while exploring the power of combinations, seeking to drive deeper and more durable responses.” Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, added, “Prognosis of patients with unresectable liver cancer is often limited and diagnosis is significantly delayed, with a majority of the cases getting diagnosed in an advanced and unresectable stage. Hence, novel treatment alternatives become paramount for improving long-term survival. The approval for Tremelimumab underscores our unwavering commitment to bringing life changing medicines to Indian patients.” 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 five-year overall survival (OS) of 33 per cent, 10 per cent and 2 per cent respectively.