AstraZeneca Pharma India receives CDSCO approval for Durvalumab indication in endometrial cancer
Approval covers import and marketing of Imfinzi for use with chemotherapy in first-line treatment
AstraZeneca Pharma India 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 under the 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. This is followed by maintenance treatment with Durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient.
The company stated that the receipt of this permission enables the marketing of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL in India for the specified indication, subject to receipt of related statutory approvals, if any.
The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and the company requested that the intimation be taken on record.