Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

If approved, Tagrisso will be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.

Tagrisso was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

Each year in the US, there are nearly 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 newly diagnosed individuals with NSCLC are unresectable.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Priority Review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available. We look forward to close collaboration with the FDA on an accelerated path to bring Tagrisso to patients as a potential new standard of care as quickly as possible. Tagrisso continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years and reinforcing the importance of testing for EGFR mutations at the time of diagnosis.”

The sNDA is based on data from the LAURA Phase III trial recently presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.( previously cited). In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review (bicr). median progression-free survival (pfs) was 39.1 months in patients treated with tagrisso versus 5.6 months for placebo. importantly, a clinically meaningful pfs benefit was observed across all prespecified subgroups including sex, race, type of egfr mutation, age, smoking history, and prior crt.

Overall survival (OS) data showed a favourable trend for Tagrisso, although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint.