Osimertinib Granted Priority Review designation for EGFR-mutated Non–small Cell Lung Cancer

The FDA has granted osimertinib (Tagrisso) a priority review designation to a supplemental new drug application for the adjuvant treatment of patients with early-stage EGFR-mutated non—small cell lung cancer (NSCLC) following complete tumor resection with curative intent.¹ The application was based on data from the pivotal phase 3 ADAURA trial, which showed that adjuvant osimertinib resulted in a statistically significant and clinically meaningful improvement in disease-frees survival (DFS) in patients with stage IB/II/IIIA EGFR-mutated NSCLC.2 Specifically, the targeted agent resulted in a 79% reduction in the risk of disease recurrence or death (HR, 0.21; 95% CI, 0.16-0.28; P <.0001).

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the application during the first quarter of 2021.

“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients,” said Dave Frederickson, executive vice president of the Oncology Business Unit at AstraZeneca.¹ “This expedited review underscores the unprecedented disease-free survival benefit [osimertinib] brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible.”

The double-blind, randomized, placebo-controlled phase 3 trial enrolled patients 18 years of age or older with a World Health Organization (WHO) performance status of 0 or 1 and confirmed primary nonsquamous NSCLC who underwent a complete resection with negative margins. Patients were stratified by stage (IB vs II vs IIIA), EGFR mutational status (exon 19 deletion vs L858R), and race (Asian vs non-Asian).

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