AstraZeneca Pharma India has obtained approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute Durvalumab (120 mg/2.4 mL and 500 mg/10 mL solution for infusion) for an additional indication. The approval is granted for use in combination with chemotherapy as a neoadjuvant treatment, followed by Durvalumab monotherapy post-surgery, specifically for patients with resectable (tumors ≥ 4 cm and/or node-positive) non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
According to the GLOBOCAN 2022 data, lung cancer is the fourth leading cause of cancer-related mortality in India. NSCLC accounts for a significant proportion of these cases, with about 15 per cent of patients having resectable disease, this data underscores the importance of targeted treatment options.
Emphasising the importance of this approval Dr Anil Kukreja, Vice-President of Medical Affairs and Regulatory at AstraZeneca Pharma India said, “We are continuously advancing our scientific understanding of cancer to develop life-changing treatments that improve patient survival. The approval of Durvalumab is a step towards delivering impactful therapies. The AEGEAN trial demonstrates that this Imfinzi-based regimen significantly improved outcomes in resectable lung cancer, further validating the importance of early intervention in lung cancer treatment.”
Dr Sanjeev Panchal, Managing Director and Country President of AstraZeneca Pharma India said, “Patients remain at the heart of all we do. We are committed to accelerating the delivery of innovative medicines to patients in India. Our efforts to introduce treatments like the AEGEAN regimen in early lung cancer settings reflect our dedication to transforming patient care through precision medicine.”
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