Osimertinib Receives FDA Approval for First-Line Treatment of EGFR Mutation-Positive Lung Cancer

On 19 April 2018, the United States Food and Drug Administration (FDA) approved osimertinib for patients with EGFR mutation-positive, non-small cell metastatic (stage 4) lung cancer as first-line treatment. Marketed as Tagrisso, this targeted oral medicinerequires detection of an EGFR exon 19 deletion or exon 21 L858R mutation before use.

FDA approval was based on the results of FLAURA, a multicenter, international, randomized, double-blind, active-controlled clinical trial. It enrolled patients with EGFR exon 19 deletions or exon 21 L858R mutations and inoperable or metastatic non-small cell lung cancer, totaling 556 patients. They were randomized 1:1 to two groups. One received oral osimertinib 80 mg once daily; the other received standard first-line EGFR-positive lung cancer treatment [gefitinib 250 mg (Iressa) or erlotinib 150 mg (Tarceva)]. %20 of patients in the standard-treatment group later received osimertinib.

FLAURA Study Results;

• Median time during which treatment controlled the disease, or progression-free survival, was 18.9 months with osimertinib versus 10.2 months with standard treatment.
• The overall response rate was % 77 for osimertinib and % 69 for standard treatment.
• Estimated median response durations for osimertinib and standard treatment were 17.6 and 9.6 months, respectively.

The most common side effects were diarrhea, rash, dry skin, nail-related side effects, mouth sores and decreased appetite (occurring in at least % 20 of osimertinib-treated patients). Serious adverse effects were reported in % 4. The most frequent serious effects (≥1%) were pneumonia (% 2.9), pneumonitis (% 2.1) and pulmonary embolism (% 1.8).

The recommended osimertinib (Tagrisso) doseis 80 mg orally once daily, with or without food.

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