AstraZeneca Pharma India Receives Approval for Durvalumab Solution for First-line Endometrial Cancer Treatment
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import and distribute Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL (Brand Name: Imfinzi) for an additional indication. This approval allows Durvalumab in combination with carboplatin and paclitaxel to be used 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 (MMR). 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 is subject to the receipt of related statutory approvals.
Key Highlights
- AstraZeneca Pharma India Limited received approval for Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL (Brand Name: Imfinzi) for an additional indication.
- 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.
- Durvalumab as monotherapy is indicated for maintenance treatment in endometrial cancer that is mismatch repair deficient (MMR).
- 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 is subject to the receipt of related statutory approvals.