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FDA grants orphan drug designation to Gilotrif for advanced squamous cell lung carcinoma
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The FDA granted orphan drug designation to afatinib for the treatment of patients with squamous cell lung carcinoma who experienced disease progression following treatment with first-line chemotherapy, according to a press release from the drug’s manufacturer.
The FDA granted the orphan drug status and accepted the filing application for afatinib (Gilotrif, Boehringer Ingelheim) based on data from the phase 3 LUX-Lung 8 trial. The study evaluated afatinib compared with erlotinib (Tarceva; Genentech, Astellas) in patients with advanced squamous cell carcinoma of the lung who progressed after treatment with first-line platinum-based chemotherapy.
Results of the LUX-Lung 8 trial showed that patients who received afatinib experienced superior PFS and OS — the study’s primary and secondary endpoints — compared with patients who received erlotinib, according to the press release. More patients treated with afatinib also experienced improved health-related quality-of-life (36% vs. 28%).
The rate of serious adverse events appeared comparable between the study arms; however, more patients who received afatinib experienced grade 3 diarrhea (10% vs. 2%) and grade 3 stomatitis (4% vs. 0%).
Afatinib is currently approved for the first-line treatment of specific types of EGFR mutation-positive non–small cell lung cancer.
The European Medicines Agency also has accepted the filing application for afatinib for patients with squamous cell carcinoma.
"Working with the US and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis,” Jörg Barth, MD, corporate senior vice president and therapy area head of oncology at Boehringer Ingelheim, said in a press release. “This is an encouraging prospect for Boehringer Ingelheim, as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer."
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.