AstraZeneca Receives CDSCO Approval For Tremelimumab Combination In India
New Delhi, June 2 (TNA) AstraZeneca Pharma India Ltd. (AstraZeneca India), a science-led biopharmaceutical company, announced it 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.
GLOBOCAN INDIA 2020 reports more than 30,000 new local cases of HCC are diagnosed every year, making it the 10th most common cause of cancer in India. It’s high mortality rate makes it the 8th most common cause of cancer related deaths in the country.
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 majority of the cases getting diagnosed in advanced and unresectable stage. Hence, novel treatment alternatives become paramount for improving long-term survival. The approval for Tremelimumab underscores our unwavering commitment of brining lifechanging medicines to Indian patients”.
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).
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 5-year survival rate for HCC is about 18%; localised, regional and metastatic HCC have a 5-year overall survival (OS) of 33%, 10% & 2% respectively.
HIMALAYA was a randomised, open-label, multicentre, global Phase III trial of Durvalumab monotherapy and a regimen comprising a single priming dose of Tremelimumab 300mg added to Durvalumab 1500mg followed by Durvalumab every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.
The primary endpoint was overall survival (OS) for the combination versus sorafenib and key secondary endpoints included OS for Durvalumab versus sorafenib, objective response rate and progression-free survival (PFS) for the combination and for Durvalumab alone. The trial showed a positive and significant benefit for OS for the combination of Tremelimumab & Durvalumab vs Sorafenib.