FDA Approves Osimertinib for Treatment of Non-Small Cell Lung Cancer


Osimertinib surpassed standard of care with a median progression-free survival of 18.9 months in clinical trials.

Officials with the FDA have approved osimertinib (Tagrisso, AstraZeneca) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, according to a press release.

The approval is based on data from the phase 3 FLAURA trial. In the trial, researchers compared osimertinib to current first-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib and gefitinib, in previously untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) NSCLC.

Osimertinib is already approved in the United States for the second-line treatment of patients with metastatic EGFRm NSCLC, whose disease has progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test.

According to data from the trial, osimertinib met the primary endpoint of progression-free survival (PFS) with a median PFS of 18.9 months compared with 10.2 months in patients treated with gefitinib or erlotinib. Osimertinib also demonstrated an objective response rate (ORR) of 77% and median duration of response of 17.6 months.

Additionally, osimertinib’s safety data from the trial were in line with those observed in prior clinical trials. The drug was generally well tolerated, with grade 3 or higher adverse events occurring in 34% of patients taking osimertinib and 45% in the comparator arm.

The most common adverse reactions associated with osimertinib were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite.

“The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm,” Suresh S. Ramalingam, MD, principal investigator of the FLAURA trial, said in the press release. “Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors.”


US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer [news release]. Astrazeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-tagrisso-as-1st-line-treatment-for-EGFR-mutated-non-small-cell-lung-cancer.html# Accessed April 19, 2018.

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