AstraZeneca India receives CDSCO approval for Durvalumab for specified additional indication
Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, is indicated for the treatment of patients with resectable non-small cell lung cancer
AstraZeneca Pharma has received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for the below mentioned additional indication, subject to the receipt of related statutory approvals, if any.
Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
According to GLOBOCAN 2022 data, lung cancer remains the fourth most common cause of cancer-related mortality in India. Around 15 per cent of patients with NSCLC in India have resectable disease representing a significant patient population.
The AEGEAN trial shows this novel Imfinzi-based regimen meaningfully improved outcomes in resectable lung cancer, further validating the importance of moving lung cancer diagnosis and treatment to earlier stages of the disease where patients have the highest potential for cure.
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