
AstraZeneca Pharma India Ltd Receives Permission for Imfinzi's Additional Indication
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) for an additional indication. The approval allows Durvalumab in combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). This permission marks the way for marketing Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
Key Highlights
- AstraZeneca Pharma India Ltd receives permission for Imfinzi's additional indication
- Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) approved for an additional indication
- Indication for first-line treatment of adults with primary advanced or recurrent endometrial cancer
- Approval for maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR)
- Subject to the receipt of related statutory approvals for marketing in India