FDA grants priority review to AstraZeneca's Tagrisso for unresectable EGFRm lung cancer

AstraZeneca has announced that the FDA has granted a priority review for its application seeking approval of Tagrisso (osimertinib) for treating adults with unresectable, stage III EGFR-mutated non-small-cell lung cancer (NSCLC) following chemoradiotherapy. This application targets patients whose tumors possess exon 19 deletions or exon 21 (L858R) mutations. The FDA is expected to make a decision on this filing in the fourth quarter of the year.

Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca, emphasized the significance of the priority review. She pointed out the importance of this development for patients who currently do not have targeted treatment options available. If approved, Tagrisso, a third-generation EGFR tyrosine kinase inhibitor, could potentially become a new standard of care for these patients.

The application is underpinned by findings from the Phase III LAURA study. Top-line results from this study were disclosed in February, with detailed findings presented at the American Society of Clinical Oncology (ASCO) annual meeting. The data revealed that Tagrisso achieved the primary goal of the trial, reducing the risk of disease progression or death by 84% compared to placebo. The median progression-free survival for patients treated with Tagrisso was 39.1 months, compared to just 5.6 months for those on placebo. This benefit was consistent across various prespecified subgroups. Additionally, a positive trend in overall survival was observed favoring Tagrisso.

FirstWord is currently conducting a poll among physicians in the US and Europe to gauge the impact of the LAURA study data on their use of Tagrisso in clinical practice.

At present, Tagrisso is approved in the US for the first-line treatment of metastatic EGFR-mutated NSCLC and as adjuvant therapy for resectable NSCLC following surgery. Within NSCLC, Tagrisso is also being investigated in the neoadjuvant and early-stage adjuvant resectable settings through the ongoing late-stage studies, NeoADAURA and ADAURA2, respectively.

Tagrisso was the leading product in AstraZeneca’s oncology portfolio last year, generating nearly $5.8 billion in global sales. Analysts at Jefferies forecast that revenue from Tagrisso will reach $7.4 billion by 2028, with a peak expected at $7.7 billion.

Overall, the potential approval of Tagrisso for this new indication could represent a significant advancement in the treatment landscape for patients with stage III EGFR-mutated NSCLC, offering a much-needed targeted therapy option.