AstraZeneca Pharma (India) Ltd. received approval to import and distribute Durvalumab 120 mg/2.4 mL and 500 mg/10 mL.
The pharma major received the approval from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, according to an exchange filing released on Monday.
This approval allows Durvalumab to be used together with chemotherapy before surgery, and then as a single treatment afterward.
Durvalumab is meant for patients with resectable non-small cell lung cancer who have tumors larger than 4 cm or have cancer in the lymph nodes. Also, it can be used for patients who do not have known mutations in the epidermal growth factor receptor or rearrangements in anaplastic lymphoma kinase, said the filings.
The receipt of this permission sets the stage for the launch of Imfinzi in India.
Shares of AstraZeneca Pharma (India) closed 1.69% lower at Rs 6746.45 apiece, compared to a 0.45% rise in the benchmark BSE Sensex.
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