AZ’s Tagrisso scores priority review from FDA

AstraZeneca’s EGFR-tyrosine kinase inhibitor Tagrisso has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of early-stage EGFR-mutated lung cancer.

In particular, AZ is seeking approval for Tagrisso (osimertinib) for the adjuvant treatment of patients with early stage (Ib, II, IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

AZ’s supplemental new drug application (SNDA) for Tagrisso was based on results from the ADAURA phase III trial, which demonstrated statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with stage II and IIa EGFR-mutated NSCLC.

It also demonstrated the same outcomes in the overall trial population of patients with stage Ib/IIIa disease, a key secondary endpoint.

Although up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease.

Nearly half of patients diagnosed with stage Ib NSCLC and over three quarters of patients diagnosed in stage IIIa experience disease recurrence within five years.

“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 Fredrickson, executive vice president, oncology business unit, AZ.

“This expedited review underscores the unprecedented disease-free survival benefit Tagrisso 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,” he added.