CDSCO nod to AstraZeneca cancer drug Tremelimumab
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.
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Bangalore: AstraZeneca Pharma India has announced that the 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 drug firm said.
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