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FDA approves frontline Tagrisso for EGFR-mutant non-small cell lung cancer
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The FDA approved osimertinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
Osimertinib (Tagrisso, AstraZeneca) — an EGFR tyrosine kinase inhibitor that selectively inhibits EGFR TKI-sensitizing and EGFR T790M-resistance mutations — previously had been approved for second-line treatment of patients with metastatic EGFR-mutated NSCLC whose disease progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation.
The FDA based the approval for use in the first-line setting on results from the phase 3 FLAURA trial, which included 556 previously untreated patients with locally advanced or metastatic EGFR-mutated NSCLC.
Patients received osimertinib or a standard EGFR TKI — either erlotinib (Tarceva; Genentech, Astellas Oncology) or gefitinib (Iressa, AstraZeneca).
Osimertinib extended PFS compared with standard EGFR TKI therapy (18.9 months vs. 10.2 months; HR 0.46; 95% CI, 0.37-0.57).
Researchers observed these results across patient subgroups, including those with or without central nervous system metastases.
The New England Journal of Medicine previously published the results from this study.
The safety profile of osimertinib appeared consistent with previous clinical trials. Researchers observed adverse events among 34% of osimertinib-treated patients. The most common adverse events included diarrhea (58%), rash (58%), dry skin (36%), nail toxicity (35%), stomatitis (29%), fatigue (21%) and decreased appetite (20%).
“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, deputy director of Winship Cancer Institute of Emory University, said in a company-issued press release. “Osimertinib provides robust improvements in PFS with no unexpected safety signals compared [with] the previous generation of EGFR inhibitors.”
The FDA previously granted priority review to osimertinib for the frontline indication.
Editor's note: On April 20, we corrected this article to specify that osimertinib is approved in the second-line setting for patients with metastatic EGFR-mutated NSCLC, whose disease has progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation. The Editors regret this error.