Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. The US approval follows the recent marketing authorisation of Gilotrif in this patient population by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the US for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

“We are pleased to bring a proven therapy to patients suffering from advanced squamous cell carcinoma of the lung who have progressed despite chemotherapy,” said Sabine Luik, MD, senior vice president, medicine & regulatory affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval is further evidence of Boehringer Ingelheim’s strong commitment to bringing new treatment options to the lung cancer community.”

Squamous cell carcinoma (SqCC) of the lung is associated with a poor prognosis, limited survival and symptoms like cough and dyspnea. The median overall survival (OS) after diagnosis of advanced SqCC is around one year.

LUX-Lung 8 clinical trial investigator Shirish Gadgeel, MD, leader of the thoracic oncology multidisciplinary team at the Karmanos Cancer Center, Detroit, commented, “The overall survival data and significant delay in lung cancer progression seen in the global head-to-head phase III trial demonstrated that Gilotrif is an effective new treatment option in this patient population.”

The sNDA was based on results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumours progressed after first-line chemotherapy. Gilotrif, compared to erlotinib, demonstrated significant delay in progression of lung cancer (PFS, progression-free survival, primary endpoint), reducing the risk of cancer progression by 18 per cent; significant improvement in overall survival (OS, key secondary endpoint), reducing the risk of death by 19 per cent; significantly improved disease control rate (51 per cent vs 40 per cent; P=0.002).

The most common adverse reactions observed with Gilotrif (reported in at least 20 per cent of study patients) were diarrhea (75 per cent), rash or acne (70 per cent), stomatitis (mouth sores) (30 per cent), decreased appetite (25 per cent), and nausea (21 per cent).

LUX-Lung 8 (NCT01523587) is part of the Gilotrif LUX-Lung program – the largest collection of clinical trials of any EGFR tyrosine kinase inhibitor (TKI), with over 3,760 patients across eight studies conducted around the world. The comprehensive LUX-Lung program includes two pivotal studies in the first-line setting for EGFR mutation-positive patients, LUX-Lung 3 and LUX-Lung 6, which compared Gilotrif to chemotherapy regimens. In addition, the program included two head-to-head studies (LUX-Lung 7 and LUX-Lung 8) of Gilotrif versus first-generation EGFR TKIs gefitinib and erlotinib, respectively. The LUX-Lung programme has involved over 680 sites in 40 countries, reflecting the strong partnership between Boehringer Ingelheim and the lung cancer specialist community.