MediPharma Times Drug Approval

AstraZeneca India Gets CDSCO Green Light for New Use of Osimertinib in Advanced EGFR-Mutated Lung Cancer

MediPharma Times Drug Approval

In a major stride for lung cancer treatment in India, AstraZeneca India Pharma has secured approval from the Central Drugs Standard Control Organisation (CDSCO) for an expanded indication of its targeted therapy, Osimertinib, in 40mg and 80mg tablet forms.

The new approval allows Osimertinib to be used as monotherapy in patients with unresectable (Stage III) Non-Small Cell Lung Cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and whose disease remains stable following platinum-based chemoradiation therapy. This marks a first-in-class treatment advancement for EGFR-mutated NSCLC in the post-chemoradiation setting.

The regulatory nod is backed by robust clinical evidence from the global Phase III LAURA trial, which showcased Osimertinib’s ability to significantly delay disease progression—including progression in the central nervous system—across various patient subgroups.

Lung cancer remains a major health burden in India, ranking fourth in cancer-related deaths as per GLOBOCAN 2022 data. NSCLC accounts for nearly 85% of all lung cancer cases, with EGFR mutations present in 33–37% of Indian patients with adenocarcinoma, a leading subtype of NSCLC.

With this extended approval, Osimertinib opens a new line of defense for a sizable group of patients who previously had limited treatment options after chemoradiation, offering renewed clinical hope and longer disease-free intervals.