AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval

AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily regimen of Tagrisso following chemoradiotherapy (CRT), which demonstrated a significant reduction in the risk of disease progression or death compared to placebo. The safety and tolerability profiles were found to be consistent with the established profile of the drug.

In a separate development, AstraZeneca received regulatory approval from the US Food and Drug Administration (FDA) for the use of Tagrisso in combination with chemotherapy for the treatment of locally advanced or metastatic EGFR-mutated NSCLC. This decision was based on Phase III data that showed the addition of chemotherapy to Tagrisso improved median PFS to 25.5 months from 16.7 months when Tagrisso was used alone.

These developments highlight Tagrisso’s potential as a significant treatment option in the management of EGFR-mutated NSCLC and underscore AstraZeneca’s commitment to advancing targeted therapies for lung cancer.- Flcube.com

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