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.
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.
The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India, it added.
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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.
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AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited (AZPIL) is the operating company and covers manufacturing, sales and marketing activities of the company in India. It is a listed company and is a subsidiary of AstraZeneca Plc, UK. The company has an innovative portfolio in crucial areas of healthcare including cardiovascular, renal & metabolic diseases, oncology and respiratory.
AstraZeneca India Private Limited (AZIPL) hosts the IT (Global Technology Centre), Global Business Services (Global Commercial Operations) and GMD (Global Medicines Development). AZIPL is governed by a Board of Directors.
