New Delhi, February 10 AstraZeneca Pharma India Ltd announced on Tuesday that it has received approval from India's drug regulator to market the Durvalumab solution for infusion, used in cancer treatment, for an additional indication.
The company has received approval from the Central Drugs Standard Control Organisation and the Directorate General of Health Services to import and distribute the Durvalumab solution for infusion, with strengths of 120 mg/2.4 ml and 500 mg/10 ml (brand name Imfinzi), for the specified additional indication, AstraZeneca Pharma said in a regulatory filing.
This approval indicates that 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 a monotherapy in endometrial cancer that is deficient in mismatch repair (dMMR).
The receipt of this approval paves the way for the marketing of the Durvalumab solution for infusion, with strengths of 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.
