The approval introduces a game-changing shift in the therapeutic landscape for LS-SCLC, a particularly aggressive subtype of lung cancer that accounts for roughly 15 per cent of all lung cancer cases

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organization (CDSCO) for an expanded indication of Durvalumab, marking a significant development in lung cancer treatment, according to The Economic Times. The regulatory nod allows the import, sale and distribution of Durvalumab (120 mg/2.4 mL and 500 mg/10 mL) for patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has remained stable following platinum-based chemoradiation therapy (CRT).

Transforming the LS-SCLC Treatment Landscape

This approval introduces a game-changing shift in the therapeutic landscape for LS-SCLC, a particularly aggressive subtype of lung cancer that accounts for roughly 15 per cent of all lung cancer cases. While most small cell lung cancer (SCLC) cases are diagnosed in advanced stages, a considerable portion of Indian patients present with the limited-stage form, underscoring the need for improved early treatment strategies, according to The Economic Times.

Bridging a Critical Treatment Gap

Historically, treatment for LS-SCLC was restricted to CRT, with limited consolidation options to enhance long-term outcomes. Durvalumab’s approval fills this critical gap, becoming the first approved consolidation therapy in this setting. The breakthrough is backed by data from the ADRIATIC clinical trial, which demonstrated that Durvalumab significantly extends progression-free and overall survival when administered after CRT, compared to a placebo.

Stock Performance and Financials

As of March 11, 2025, AstraZeneca Pharma India Ltd. (ASTRAZEN) is trading at Rs 27,655.20 on NSE and Rs 27,675.50 on BSE, with a market cap of Rs 18,685 Cr; the stock has gained 2.23 per cent this year and 11.49 per cent in the last five days while reporting a net profit of Rs 730.85 Cr in its latest quarter.

The Growing Burden of Lung Cancer in India

Lung cancer accounts for approximately 5.9 per cent of all cancer cases and 8.1 per cent of cancer-related deaths in India. They also remain one of the deadliest cancers in India, ranking as the fourth leading cause of cancer-related mortality. With small cell lung cancer (SCLC) making up about 15 per cent of these cases, Durvalumab’s approval offers a crucial treatment advancement, particularly for the 25 per cent of Indian SCLC patients diagnosed at a limited stage. By serving as the first approved consolidation therapy post-CRT, this drug has the potential to improve survival rates and redefine early-stage treatment strategies.

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Lung cancer accounts for approximately 5.9 per cent of all cancer cases and 8.1 per cent of cancer-related deaths in India

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With this development, AstraZeneca continues to strengthen its commitment to oncology innovation, working toward a future where earlier detection and targeted therapies become the cornerstone of cancer management in India.