LONDON (ShareCast) - (Sharecast News) - AstraZeneca announced on Thursday that 'Tagrisso', or osimertinib, has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, stage three epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), whose disease had not progressed after platinum-based chemoradiation therapy (CRT).
The FTSE 100 pharmaceuticals giant said the approval was specifically for patients with exon 19 deletions or exon 21 (L858R) mutations, as determined by an FDA-approved test.

It said the FDA's decision followed a priority review, heavily based on findings from the LAURA phase three trial, which were presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine.

In the study, Tagrisso showed a significant clinical benefit, reducing the risk of disease progression or death by 84% compared to placebo.

The median progression-free survival (PFS) for patients treated with Tagrisso was 39.1 months, a notable increase from the 5.6 months observed in the placebo group.

While overall survival (OS) data remained immature and was still being monitored, AstraZeneca said the approval marked a substantial advancement in treatment options for patients with the specific form of lung cancer.

Each year, over 200,000 people in the US are diagnosed with lung cancer, with NSCLC accounting for 80% to 85% of cases.

Among NSCLC patients, about 15% have EGFR mutations, and nearly 20% present with unresectable tumours.

The safety and tolerability profile of Tagrisso in the LAURA trial aligned with its established safety record, with no new concerns identified.

Tagrisso was already approved for several indications, including first-line treatment of metastatic EGFRm NSCLC and as an adjuvant therapy for early-stage disease.

The drug was currently under review by regulatory bodies in other countries for the newly-approved indication.

"The approval of Tagrisso for patients with stage three, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before," said Dave Fredrickson, executive vice-president of AstraZeneca's oncology business unit.

"The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit."

Reporting by Josh White for Sharecast.com.

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