FDA Approves Tagrisso for Non-Small Cell Lung Cancer

The FDA has approved osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed while on or after EGFR tyrosine kinase inhibitor therapy.

Tagrisso first received accelerated approval for this indication in November 2015, based upon an overall response rate of 59% among 411 patients in 2 single-arm trials.
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The current approval is based upon the results of a randomized, multicenter open-label, active-controlled trial in patients with metastatic EGFR T790M mutation-positive NSCLC whose disease had progressed after first-line EGFR tyrosine kinase inhibitor therapy. All patients had EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test.

The 419 patients were randomly assigned to receive either osimertinib 80 mg orally once daily or platinum-based doublet chemotherapy. Those in the chemotherapy arm were offered osimertinib at radiological progression based upon investigator and blinded independent central review.

Overall, the estimated progression-free survival (PFS) with osimertinib was 10.1 months, compared with 4.4 months with chemotherapy. Overall response rate was 65% in the osimertinib arm compared with 29% in the chemotherapy arm.

The most serious adverse reactions reported with the drug were interstitial lung disease/pneumonitis, cardiomyopathy, keratitis, and QTc interval prolongation. The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, and fatigue.

—Michael Potts

Reference:

Osimertinib (TAGRISSO) [press release]. FDA. March 30, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm549683.htm.