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FDA Approvals, News & UpdatesLung CancerNewsworthy

Tagrisso Now Approved as First Treatment for Metastatic NSCLC and EGFR Mutations

May 2018 – Cancer Biomarkers and Molecular Testing

On April 18, 2018, the FDA approved Tagrisso (osimertinib; from AstraZeneca) as the first treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Patients who received Tagrisso had a longer period (18.9 months) without cancer progression versus 10.2 months with Iressa (gefitinib) or Tarceva (erlotinib). Among the patients who responded to treatment, the average duration of response was 17.6 months with Tagrisso versus 9.6 months with Iressa or Tarceva.

The most common side effects with Tagrisso are diarrhea, rash, dry skin, and decreased appetite.

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Last modified: June 28, 2018

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