New Delhi, June 1
AstraZeneca Pharma India on Thursday said 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 drug firm said.
The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India, it added.
The 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, AstraZeneca Pharma said.
“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,” AstraZeneca India Country President and Managing Director Sanjeev Panchal noted.