AstraZeneca Pharma gets approval to launch cancer drug in India

24 Sep 2024 , 10:54 AM

AstraZeneca Pharma India Ltd announced Monday (September 23) that it has got approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute durvalumab (Imfinzi) for an additional indication in India.

This is to inform you that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, to import and distribute Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion (Imfinzi), according to a stock exchange filing.

The said indication is for the use of durvalumab in combination with chemotherapy as a neoadjuvant treatment, followed by durvalumab monotherapy after surgery. This study broadens durvalumab’s therapeutic usage in NSCLC by targeting tumours 4 cm or larger as well as node-positive patients.

Durvalumab (IMFINZI) is indicated for the treatment of patients with resectable (tumours 4 cm and/or node-positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

The business stated that the granting of this clearance allows for the marketing of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion (Imfinzi) in India for the indicated new indication, subject to the receipt of any necessary legislative permits.

At around 10.34 AM, AstraZeneca Pharma was trading 0.85% lower at ₹11,680 per piece, against the previous close of ₹11,780 on NSE. The counter touched an intraday high and low of ₹11,738, and ₹11,516, respectively.

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