Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates


On January 12, 2018, afatinib (Gilotrif; Boehringer Ingelheim) received FDA approval as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) associated with nonresistant EGFR mutations as identified via an FDA-approved test. Afatinib received orphan drug status for this indication, and was approved under the FDA priority review process.

Afatinib 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 patients with metastatic, squamous NSCLC that progressed with platinum-based chemotherapy.

The FDA approval of this new indication for afatinib was based on durable responses in 32 patients with metastatic NSCLC and nonresistant EGFR mutations other than exon 19 deletions or exon 21 L858R substitutions. The patients were enrolled in 1 of 3 clinical trials, and received afatinib 40 mg or 50 mg, orally, once daily.

The overall response rate was 66% (95% confidence interval, 47-81); among the 21 patients who responded to treatment, the response lasted ≥12 months in 52% of patients and ≥18 months in 33% of patients.

The most common (≥20%) adverse reactions reported with afatinib were diarrhea, rash, acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus.