AstraZeneca Pharma India Gets CDSCO Approval for Imfinzi

AstraZeneca Pharma India on Monday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, Government of India, to import and market Durvalumab Solution for Infusion under the brand name Imfinzi for an additional indication.

The approval enables Durvalumab to be employed together with carboxoplatin and paclitaxel as the initial-line treatment of grownups with initial advanced or recurring endometrial cancer who are qualified to experience systemic treatment.

This primary therapy will be followed by the maintenance therapy with Durvalumab monotherapy in patients with endometrial cancer that lacks mismatch repair deficiency.

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Under this regulatory approval, AstraZeneca Pharma India is permitted to use Imfinzi in India in two doses of 120mg per 2.4 ml and 500mg per 10 ml in particular to the new treatment approval. The firm observed that commercialization of the drug is subject to the approval of other related statutory approvals, where necessary.

Its development is one of the major milestones in increasing the number of treatment modalities available to endometrial cancer patients in the country, especially those who are in need of a regimen based on targeted immunotherapy. Durvalumab is already in use in various cancer indications all over the world and the new approval expands its use in the Indian market.

The update was reported by the company on the basis of Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. To ensure that the announcement is in line with the various regulatory standards and disclosure requirements, AstraZeneca Pharma India asked stock exchanges to record the information.