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FDA Approvals, News & UpdatesLung CancerNewsworthy

Gilotrif Approved as First Treatment for Metastatic Lung Cancer and EGFR Mutations

May 2018 Cancer Biomarkers and Molecular Testing – June 28, 2018

On January 12, 2018, the FDA approved Gilotrif (afatinib; from Boehringer Ingelheim) for use as the first treatment in patients with metastatic non–small-cell lung cancer (NSCLC) associated with nonresistant EGFR mutations, as identified by an FDA-approved test.

Gilotrif was previously approved for patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test, and for metastatic, squamous NSCLC that progressed with platinum-based chemotherapy.

This new indication for Gilotrif was based on durable responses in patients with metastatic NSCLC and nonresistant EGFR mutations other than exon 19 deletions or exon 21 L858R substitutions.

Overall, 66% of patients responded to treatment with Gilotrif. Among the 21 patients who responded to treatment, the response lasted 12 months or longer in half of the patients and 18 months or longer in one-third of patients.

The most common side effects with Gilotrif are diarrhea, rash, paronychia, dry skin, decreased appetite,nausea, vomiting, and pruritus.

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Last modified: July 20, 2018

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