FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif for treatment of advanced SCC of the lung

Boehringer Ingelheim has announced that both FDA and EMA have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA — a status given to a product intended for the treatment of a rare disease or condition.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim commented: "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. 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 submissions are based on data from the Phase III LUX-Lung 8 trial that compared Gilotrif(®) (afatinib) to Tarceva (erlotinib) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19% compared to erlotinib in this patient population.

In the LUX-Lung 8 trial, an improvement in quality of life and control of cancer symptoms was observed with afatinib versus erlotinib. More patients had improved overall health-related quality-of-life with afatinib than with erlotinib (36% vs. 28%). Significantly more patients had an improvement in cough with afatinib than with erlotinib (43% vs. 35%). Differences in the proportion of patients with improved dyspnea (51% vs. 44%) and pain (40% vs. 39%) were not significant for afatinib versus erlotinib. Afatinib significantly delayed time to deterioration of dyspnea compared with erlotinib. Time to deterioration of both pain and cough was similar for afatinib versus erlotinib.

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhea: 10% vs. 2%; grade 3 stomatitis: 4% vs. 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs. 6%).