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Breakthrough Therapy Designation Granted for Osimertinib as First-Line Treatment for EGFR-Positive Non–Small Cell Lung Cancer

By: Sarah Jackson
Posted: Friday, October 13, 2017

The U.S. Food and Drug Administration (FDA) granted osimertinib (Tagrisso) Breakthrough Therapy designation for first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer (NSCLC), as disclosed in a press release by AstraZeneca on October 9, 2017.

The designation for osimertinib was based on the findings of a phase III trial that compared the standard-of-care EGFR tyrosine kinase inhibitor (TKI) with osimertinib. In the double-blind randomized FLAURA study, 556 patients from 30 countries were given osimertinib orally.  The median progression-free survival in those treated with osimertinib was 18.9 months, as compared with 10.2 months for the patients given EGFR TKIs alone. Improvements were seen in all prespecified subgroups, including those with and without brain metastases.

In patients treated with osimertinib, diarrhea was reported in more than half, and dry skin was noted in about one-third. Thirty-four percent of those given osimertinib had a grade ≥ 3 adverse effect, as compared with 45% in the comparator arm (erlotinib or gefitinib). Thirteen percent of patients given osimertinib discontinued treatment due to an adverse effect.