First EGFR inhibitor approved in locally advanced unresectable (stage III) NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations post- chemoradiation
New approval addresses a significant unmet need in post-chemoradiation NSCLC patients
Bangalore, 29 May 2025: AstraZeneca India Pharma Ltd. (AZPIL), a global, science-led, patient focused pharmaceutical company, today announced it has received approval from the Central Drugs Standard Control Organisation (CDSCO), for the import, sale, and distribution of Osimertinib 40mg and 80mg tablets for an additional indication. The approval marks a critical step forward with Osimertinib as monotherapy in the treatment of patients with locally advanced, unresectable (Stage III) Non-Small Cell Lung Cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
This new indication represents a first-in-class treatment option in a setting for EGFR-mutated NSCLC post-chemoradiation. The approval follows compelling evidence from the Phase III LAURA trial[1], and demonstrated significant clinical benefits in delaying disease progression across different sub-groups, including CNS progression free survival with Osimertinib.
Lung cancer continues to pose a major public health challenge in India, ranking as the fourth leading cause of cancer-related deaths, according to GLOBOCAN 2022[2]. NSCLC accounts for approximately 85% of all lung cancers[3], with EGFR mutations seen in 33–37% of Indian patients with adenocarcinoma—a major subtype of NSCLC[4]. The introduction of Osimertinib in EGFR+ locally advanced NSCLC offers renewed hope for a substantial patient population with limited options.
Dr. Sandeep Arora, Director Medical Affairs, AstraZeneca Pharma India Limited said, "This approval signifies a major advancement for patients and is backed by strong data from the Phase III LAURA trial, demonstrating Osimertinib's potential to significantly extend progression-free survival. It sets a new standard of care for individuals with stage III locally advanced unresectable, EGFR-mutated non-small cell lung cancer, offering the first targeted treatment in this setting. This underpins our commitment to scientific innovation and pushing the boundaries in cancer care."
Dr Sanjeev Panchal, Country President & Managing Director AstraZeneca Pharma India Limited said, "With Osimertinib's approval for this additional indication, we are reaching a significant milestone in redefining lung cancer treatment in India. At AstraZeneca, we are dedicated to bringing pioneering medicines to those who need them most. This approval not only reinforces our leadership in oncology but also underscores our commitment to addressing critical unmet needs and enhancing outcomes across the cancer care continuum."