FDA Approval: Osimertinib indication for EGFR T790M Mutation-positive NSCLC

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The most common serious adverse event was lung disease/pneumonitis.
The most common serious adverse event was lung disease/pneumonitis.

The US Food and Drug Administration (FDA) approved osimertinib for the treatment of EGFR T790M mutation-positive NSCLC, according to a press release.1

The approval is based on the findings of the phase 3 AURA3 study (ClinicalTrials.gov Identifier: NCT02151981), which showed a progression-free survival improvement of 5.7 months over chemotherapy (10.1 months vs 4.4 months, respectively).

The study included 419 patients with metastatic disease who were randomly assigned 2:1 to receive osimertinib 80 mg daily or a platinum-based chemotherapy.

The confirmed objective response rate with osimertinib was 65%, with an estimated median response duration of 11 months. Overall survival data are not yet available.

The most common adverse events observed in patients receiving osimertinib were “diarrhea, rash, dry skin, nail toxicity, and fatigue.” The most common serious adverse event was lung disease/pneumonitis, which occurred in 3.5% of patients.

Osimertinib is an EGFR tyrosine kinase inhibitor (TKI) manufactured by AstraZeneca Pharmaceuticals.

Reference

  1. Osimertinib (TAGRISSO) [news release]. Silver Spring, MD: US Food and Drug Administration; March 30, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm549683.htm. Accessed March 30, 2017.

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