AstraZeneca India Pharma Ltd. (AZPIL), a global, science-led, patient-focused pharmaceutical company, announced that it has received approval from India’s Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of Osimertinib (40mg and 80mg tablets) for an additional indication.
This approval marks anadvancement in the treatment of locally advanced, unresectable (Stage III) Non-Small Cell Lung Cancer (NSCLC) in patients harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease has not progressed during or following platinum-based chemoradiation therapy.
With this approval, Osimertinib becomes the first approved EGFR-TKI monotherapy in India for use after chemoradiation in Stage III NSCLC, offering a vital therapeutic advancement for patients with limited treatment options. The approval is based on strong clinical evidence from the Phase III LAURA trial, which showed that Osimertinib significantly delayed disease progression—including central nervous system (CNS) progression—in this patient population.
Lung cancer remains a critical health challenge in India, currently ranked as the fourth leading cause of cancer-related deaths, according to GLOBOCAN 2022. Non-Small Cell Lung Cancer (NSCLC) accounts for approximately 85% of all lung cancers, and EGFR mutations are seen in 33–37% of Indian patients with adenocarcinoma, a major subtype of NSCLC.
The availability of Osimertinib in this new setting could significantly impact the treatment landscape for thousands of Indian patients.
Last updated: December 26th, 2025
