CDSCO Clears AstraZeneca's Imfinzi (Durvalumab) for Additional Cancer Indication in India
New Delhi: AstraZeneca Pharma India Ltd on Tuesday said it has received permission from India's drug regulator to market Durvalumab solution for infusion used in cancer treatment for an additional indication.
The company has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, to import for sale and distribution of Durvalumab solution for infusion of strengths 120 mg/2.4 ml and 500 mg/10 ml (brand name Imfinzi) for an additional indication, AstraZeneca Pharma said in a regulatory filing.
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 which 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, it added.
