AstraZeneca Pharma India has informed that it 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. Through this approval, Durvalumab in combination with carboplatin and paclitaxel is indicated 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 as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR). The receipt of this permission paves way for the marketing of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL [Imfinzi] in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
The above information is a part of company’s filings submitted to BSE.
