AstraZeneca Pharma India Ltd on Tuesday said it has received approval from India’s drug regulator to market Durvalumab solution for infusion, used in cancer treatment, for an additional indication.
The company said it has received permission from the Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, to import, sell, and distribute Durvalumab solution for infusion in strengths of 120 mg/2.4 ml and 500 mg/10 ml, marketed under the brand name Imfinzi. The approval covers an additional indication, according to a regulatory filing.
With this approval, Durvalumab, in combination with carboplatin and paclitaxel, is approved for first-line treatment of adults with primary advanced or recurrent endometrial cancer who are eligible for systemic therapy. This is followed by maintenance treatment with Durvalumab as a single therapy in patients with endometrial cancer that is mismatch repair deficient (dMMR).
The company said this approval allows it to market Durvalumab solution for infusion in the approved strengths in India for the specified additional indication, subject to the receipt of other required statutory approvals.
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