Boehringer Ingelheim’s Giotrif has received a positive opinion for EU approval as a treatment for advanced lung cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended Giotrif for the treatment of patients with advanced squamous cell carcinoma of the lung. The drug is recommended for approval for those patients whose disease has progressed on or after treatment with platinum-based chemotherapy.
Results from the LUX-Lung 8 trial showed that the drug can delay the progression of lung cancer and significantly improve overall survival rates among those affected by this disease. The head-to-head trial also found that the drug improved quality of life and helped to control cancer symptoms.
The LUX-Lung programme, which represents the largest collection of clinical trials to date of any EGFR tyrosine kinase inhibitor, includes the LUX-Lung 8 trial.
Dr Mehdi Shahidi, medical head of solid tumour oncology at Boehringer Ingelheim, said: “Not only does it represent the potential availability of the first oral treatment option specifically approved for patients with squamous cell lung cancer, it also confirms the positive profile of afatinib…when compared to a first-generation agent.”