Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC

On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer (NSCLC).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “The Breakthrough Therapy designation acknowledges not only osimertinib’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. 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.”

FLAURA Trial

The FDA granted the Breakthrough Therapy designation based on data from the phase III FLAURA trial of osimertinib vs the standard of care—EGFR tyrosine kinase inhibitor therapy—in previously untreated patients with locally advanced or metastatic EGFR mutation–positive NSCLC. In the trial, median progression-free survival was 18.9 months for osimertinib compared with 10.2 months for the EGFR tyrosine kinase inhibitors erlotinib (Tarceva) or gefitinib (Iressa). Improvements were seen in all prespecified subgroups, including patients with and without brain metastases.

In the FLAURA trial, the safety profile of osimertinib was consistent with previous experience.  In patients treated with osimertinib, the most common adverse events were diarrhea (58%, any grade [2% grade ≥ 3]) and dry skin (32%, any grade [< 1% grade ≥ 3]). In the comparator arm group, the most common adverse events were diarrhea (57%, any grade [2% grade ≥ 3]) and dermatitis acneiform (48%, any grade [5% grade ≥ 3]). Of the patients on osimertinib, 34% had a grade ≥ 3 adverse event, compared to 45% in the comparator arm, and 13% of patients on osimertinib had an adverse event leading to treatment discontinuation, compared to 18% in the comparator arm.

On September 28, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were updated to include the use of osimertinib in the first-line treatment of patients with locally advanced or metastatic EGFR mutation–positive NSCLC. The use of osimertinib for the first-line treatment of patients with locally advanced or metastatic EGFR mutation­–positive NSCLC is not yet approved by the FDA.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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