AstraZeneca Pharma India has received 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 a new indication. This approval covers its use in treating limited-stage small cell lung cancer (LS-SCLC) in patients whose disease has not progressed after platinum-based chemoradiation therapy (CRT).

Durvalumab is now the first and only approved consolidation therapy for LS-SCLC post-CRT, representing a significant shift in treatment for this aggressive cancer, which accounts for around 15% of lung cancer cases. While most small cell lung cancer (SCLC) cases are diagnosed at advanced stages, nearly 25% of Indian patients are identified with LS-SCLC, highlighting the urgent need for improved early-stage treatment.

According to GLOBOCAN 2022, lung cancer ranks as the fourth leading cause of cancer-related deaths in India. Traditionally, LS-SCLC treatment was limited to platinum-based CRT. However, results from the ADRIATIC clinical trial, including Indian patients, demonstrated that durvalumab significantly improves progression-free and overall survival compared to a placebo.

Dr. Hardik Vasnawala, Director of Medical Affairs at AstraZeneca Pharma India, emphasized the company's commitment to advancing cancer diagnosis and treatment. This approval marks a major milestone in improving early-stage lung cancer care, reinforcing AstraZeneca’s dedication to innovation and patient-focused oncology solutions.