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.
More than 30,000 new local cases of HCC are diagnosed every year in India, making it the 10th most common cause of cancer. Its high mortality rate makes it the eight most common cause of cancer related deaths in the country.
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 per cent; localised, regional and metastatic HCC have a 5-year overall survival (OS) of 33 per cent, 10 per cent & 2 per cent respectively.
The approval for tremelimumab combination is based on results from Phase III HIMALAYA clinical trial, which was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India on 1,324 patients with unresectable, advanced HCC.
The primary endpoint was overall survival (OS) for the combination versus sorafenib and 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.
“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,” said Sanjeev Panchal, country president and MD, of AstraZeneca India.
“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,” said Dr. Anil Kukreja, vice-president, Medical Affairs and Regulatory, AstraZeneca India.
Source – ETHealth World