FDA grants breakthrough therapy designation to Tagrisso for EGFR-positive non-small cell lung cancer

The FDA granted breakthrough therapy designation to osimertinib for the first-line treatment of patients with metastatic epidermal growth factor receptor-positive non-small cell lung cancer, according to the drug’s manufacturer.

The agency’s decision included data from the double-blind, randomized phase 3 FLAURA trial, designed to compare osimertinib (Tagrisso, AstraZeneca) — an irreversible EGFR TKI —with standard-of-care EGFR TKIs in previously untreated patients with locally advanced or metastatic EGFR-positive NSCLC.

The researchers randomly assigned 556 patients to 80 mg osimertinib once daily or standard-of-care therapy — which included either 150 mg erlotinib (Tarceva; Genentech, Astellas Oncology) once daily or 250 mg gefitinib (Iressa, AstraZeneca) once daily.

PFS served as the primary endpoint. Secondary endpoints included OS, objective response rate, duration of response, disease control rate, safety and measures of health-related quality of life.

Patients treated with osimertinib demonstrated a median PFS nearly double that of the control group (18.9 months vs. 10.2 months).

The researchers observed improvements among all prespecified subgroups, including patients with and without brain metastases.

The agent appeared well tolerated, and its safety profile was consistent with previous reports.

“The breakthrough therapy designation acknowledges not only Tagrisso’s potential as a first-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said in a company-issued release. “The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.”