AstraZeneca receives approval for cancer drug combination in India
India, June 2 -- AstraZeneca Pharma India, a science-led biopharmaceutical company, 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) i...
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