AstraZeneca Pharma India Ltd. has received import and distribution licensing from the Central Drugs Standard Control Organisation (CDSCO) to market its anti-cancer therapy drug, Durvalumab (Imfinzi), in India. With this approval, the company will be able to market Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml to treat patients suffering from unresectable hepatocellular carcinoma (uHCC).

Key Highlights:
CDSCO Approval for Import and Distribution

• AstraZeneca got the approval of CDSCO, Directorate General of Health Services, Government of India.

• The company can import, market, and distribute Durvalumab (Imfinzi) in the country under the permission.

New Indication for Treatment of Cancer

• Durvalumab in combination with Tremelimumab has been approved for unresectable hepatocellular carcinoma (uHCC).

• uHCC is a state of advanced liver cancer, and the approval brings new immunotherapy treatment to the patients.

Next Steps and Market Entry

• The clearance is a precursor to commercial distribution, but the company will require additional statutory approvals prior to marketing the drug.

• Available in the market, Durvalumab will be a significant addition to the treatment of cancer in India, aiding patients who have few therapeutic choices.

With this approval, AstraZeneca Pharma India enhances its Indian oncology portfolio. The broadening of Durvalumab's indications comes in line with initiatives to improve cancer care and access to treatment. The pharma firm is now moving forward to get other approvals for starting marketing and distribution in India.