AstraZeneca Tagrisso gets USFDA priority review for unresectable, Stage III EGFR-mutated lung cancer

The Food and Drug Administration (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.

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 favorable 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.

Safety results and discontinuation rates due to adverse events were consistent with its known profile and no new safety concerns were identified.

TAGRISSO is approved as monotherapy in more than 100 countries including in the US, EU, China, and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. TAGRISSO with the addition of chemotherapy is also approved in the US and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.