FDA Expands Afatinib (Gilotrif) Label to Include Previously Treated Squamous Cell Lung Cancer

Second approval for once-daily EGFR-targeted therapy


The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. Afatinib, an oral, once-daily epidermal growth factor receptor (EGFR)-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive non–small-cell lung cancer (NSCLC).

Squamous cell carcinoma of the lung is associated with a poor prognosis, limited survival, and symptoms such as cough and dyspnea. The median overall survival after a diagnosis of advanced disease is approximately one year.

Afatinib was previously approved for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

The FDA’s approval decision was based on results from the head-to-head LUX-Lung 8 trial in patients with squamous cell carcinoma of the lung whose tumors progressed after first-line chemotherapy. Afatinib, compared with erlotinib (Tarceva, Genentech/Astellas Oncology), demonstrated:

  • A significant delay in the progression of lung cancer (progression-free survival, the trial’s primary endpoint), reducing the risk of cancer progression by 18%
  • A significant improvement in overall survival (a key secondary endpoint), reducing the risk of death by 19%
  • A significantly improved disease control rate (51% vs. 40%, respectively; = 0.002)

The most common adverse events observed in the afatinib group (n = 392) compared with the erlotinib group (n = 395) included diarrhea (75% vs. 41%, respectively), rash/acneiform dermatitis (70% vs. 70%), stomatitis (30% vs. 11%), decreased appetite (25% vs. 26%), and nausea (21% vs. 16%). Serious adverse events were reported in 44% of patients treated with afatinib. The most common serious adverse reactions reported in patients treated with afatinib included pneumonia (7%), diarrhea (5%), vomiting (5%), dehydration (3%), and dyspnea (3%). Fatal adverse events in afatinib-treated patients included interstitial lung disease (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).

Source: Boehringer Ingelheim; April 15, 2016.

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