AstraZeneca receives CDSCO’s approval for cancer drug Tremelimumab

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AstraZeneca Pharma India said Thursday that it has received approval from the Central Drug Standards Control Organization (CDSCO) to administer the cancer drug Tremelimumab Concentrate intravenously.

The drug company said the approval of Tremelimumab in combination with Durvalumab is based on results from the Phase III HIMALAYA clinical trial and is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC).

She added that the experiment was conducted in 181 centers in 16 countries, including the United States, Canada, Europe, South America and Asia, including India.

The approval paves the way for the launch of Tremelimumab solution in 20 mg/mL offerings (25 mg/1.25 mL and 300 mg/15 mL in single-dose vials) in India for specific indication, AstraZeneca Pharma said.

“This approval is in line with our ambition to transform patient outcomes and leave no patient behind. We have a broad range of scientific platforms to attack cancer while exploring the power of combinations, striving for deeper and more lasting responses,” noted AstraZeneca India Country President and Managing Director Sanjeev Panchal.

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First published: Jun 01 2023 | 9:28 PM ist