The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib; Boehringer Ingelheim). The application expands treatment to patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

Gilotrif is an oral, once-daily, epidermal growth factor receptor (EGFR)-directed therapy. It was previously approved as first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitutions as detected by an FDA-approved test.

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The sNDA is based on results from a Phase 3 clinical trial; LUX-Lung 8. In the head-to-head trial of Gilotrif and erlotinib, Gilotrif showed a significant improvement in overall survival, reducing the risk of death by 19%. Gilotrif also significantly delayed disease progression, reducing the risk of cancer progression by 18%. The LUX-Lung trials have included a total of 3,760 patients across 8 different studies.

The most common adverse reactions (reported in ≥20% of study patients) were diarrhea (75%), rash or acne (70%), stomatitis (30%), decreased appetite (25%), and nausea (21%). Gilotrif may also reduce fertility in females and males, and it is unknown whether these effects on fertility are reversible

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