AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) NSCLC, whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).
This marks Tagrisso’s sixth major indication in the US, significantly broadening the drug’s applicable patient pool. In the US, lung cancer is diagnosed in over 200,000 individuals annually, with up to 85% of these cases being NSCLC. Among them, 15% have EGFR mutated tumors, and 1 in 5 NSCLC patients have inoperable tumors.
The FDA’s decision was supported by data from the Phase III LAURA trial, the findings of which were presented at this year’s ASCO meeting. The trial results indicated that Tagrisso treatment reduced the risk of disease progression or death by 84% in the targeted patient group compared to placebo. The median progression-free survival was 39.1 months for Tagrisso versus 5.6 months for placebo. However, the overall survival data have not yet matured in the most recent evaluation.- Flcube.com
