FDA Approval Alert: Breakthrough Therapy Designation for EGFR Inhibitor


The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to an EGFR tyrosine kinase inhibitor (TKI) for the first-line treatment of EGFR-positive non-small cell lung cancer (NSCLC).

Osimertinib (Tagrisso, AstraZeneca) is a third-generation EGFR-TKI designed to inhibit both EGFR sensitizing and EGFR T790M resistance mutations. The drug is currently approved as a second-line treatment for patients with advanced NSCLC who progressed after treatment with an EGFR-TKI due to an EGFR T790M mutation. Osimertinib has now been given a breakthrough therapy designation in the first-line setting for EGFR-positive disease.

The FDA’s designation came following date form a phase III trial (FLAURA) comparing osimertinib to standard-of-care EGFR-TKI therapy in previously-untreated patients with locally-advanced or metastatic EGFR-positive NSCLC. Patients treated with osimertinib demonstrated a median progression-free survival of 18.9 months, compared with 10.2 months for those taking either erlotinib or gefitinib.


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“The Breakthrough 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,” said Sean Bohen, executive vice president, chief medical officer, AstraZeneca, in a press release (October 9, 2017). “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.”—Zachary Bessette