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AstraZeneca India Receives CDSCO Approval for Expanded Indications of Its Chemotherapy Drug

NextEdge Admin

24 Sep 2024

2 min 37 sec

AstraZeneca Pharma India Limited has announced receiving permission from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab (120 mg/2.4 mL and 500 mg/10 mL solutions for infusion) in India. The approval is contingent upon obtaining additional statutory clearances. Durvalumab is approved for use in combination with chemotherapy as a neoadjuvant treatment, followed by Durvalumab monotherapy post-surgery, for patients with resectable non-small cell lung cancer (NSCLC). Specifically, it is intended for patients with tumors larger than 4 cm or node-positive NSCLC who do not have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Lung cancer remains a significant health burden in India, ranking as the fourth leading cause of cancer-related deaths, according to GLOBOCAN 2022 data. Approximately 15% of NSCLC cases in the country are resectable, representing a notable patient population in need of advanced treatment options. This approval for Durvalumab provides a critical opportunity to improve outcomes for these patients.

Dr. Anil Kukreja, Vice-President of Medical Affairs and Regulatory at AstraZeneca Pharma India, emphasized the company’s ongoing commitment to understanding cancer and developing transformative therapies. He highlighted the significance of the AEGEAN trial, which demonstrated that the novel Imfinzi-based (Durvalumab) regimen led to meaningful improvements in outcomes for patients with resectable lung cancer. Dr. Kukreja stressed the importance of diagnosing and treating lung cancer at earlier stages, where there is a higher potential for cure. This approval aligns with AstraZeneca’s broader mission to explore innovative treatment combinations that deliver life-changing results to patients, ultimately enhancing survival and quality of life in lung cancer care.