Lung Cancer Treatment Granted Orphan Drug Status

Afatinib treats patients with advanced squamous cell carcinoma of the lung that progressed after chemotherapy.

Patients with a rare and deadly type of lung cancer may soon have a new treatment option.

The FDA last week accepted an application for afatinib (Giotrif), which treats patients with advanced squamous cell carcinoma (SCC) of the lung that progressed after treatment with first-line chemotherapy. Afatinib was also granted orphan drug designation by the FDA.

“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 and still limited treatment options,” said Jörg Barth, MD, corporate senior vice president of Boehringer Ingelheim. “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 application submission followed the phase 3 LUX-Lung 8 trial comparing afatinib to erlotinib (Tarceva) in patients with advanced SCC of the lung that progressed following first-line platinum-based chemotherapy. The trial showed treatment with afatinib resulted in superior progression-free survival, decreased the cancer progression risk by 19%, and lead to superior overall survival as the risk of death declined by 19% compared with erlotinib.

Treatment with afatinib also resulted in superior quality-of-life and cancer symptom control compared with erlotinib, as overall health-related quality-of-life improved in 36% of patients administered afatinib compared with 28% of patients administered erlotinib. Forty-three percent of patients treated with afatinib showed an improvement in cough compared with 35% of patients treated with erlotinib.

There were no significant improvements found between afatinib and erlotinib in terms of dyspnoea and pain. Afatinib was found to significantly delay the time to deterioration from dyspnoea compared with erlotinib, while the time to deterioration for both pain and cough was similar between patients treated with the 2 drugs.

The rate of severe adverse events was similar between both treatment groups. There was, however, higher incidence of severe diarrhea and mouth sores observed from treatment with afatinib compared with erlotinib, while incidence of severe rash and acne was higher in the erlotinib treatment group.