AstraZeneca's Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication

Thursday, the FDA approved AstraZeneca Plc’s AZN Tagrisso (osimertinib)​ for adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). 

Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations.

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Tagrisso is AstraZeneca’s top-selling cancer drug, and in the second quarter of 2024, it generated around $1.6 billion in sales.

The approval follows the FDA’s Priority Review based on results from the LAURA Phase 3 trial.

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo.

Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. 

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.

Approximately 15% of NSCLC patients in the US have EGFR mutations. Nearly one in five people diagnosed with NSCLC has an unresectable tumor.

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso is approved for patients with EGFR mutations in the first-line metastatic setting as monotherapy, in combination with chemotherapy, and as an adjuvant treatment for early-stage disease. 

Last week, the FDA approved AstraZeneca’s Fasenra (bevacizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can damage multiple organs.

Price Action: AZN stock is up 0.94% at $78.27 at the last check Thursday.

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