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FDA Accepts Application for Afatinib (Gilotrif) for Treatment of Advanced Lung Cancer

Pivotal trial shows delayed disease progression versus erlotinib

The FDA has accepted a filing application for afatinib (Gilotrif, Boehringer Ingelheim) 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 an “orphan drug” designation by the FDA –– a status given to a product intended for the treatment of a rare disease or condition.

The submission was based on data from the phase III LUX-Lung 8 trial, which compared afatinib with erlotinib (Tarceva, Genentech/Astellas Oncology) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from this study showed that treatment with afatinib resulted in superior progression-free survival (the trial’s primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (the key secondary endpoint), reducing the risk of death by 19%, compared with erlotinib in this patient population.

A higher incidence of severe diarrhea and stomatitis was observed with afatinib compared with erlotinib (grade-3 diarrhea: 10% vs. 2%, respectively; grade-3 stomatitis: 4% vs. 0%), whereas a higher incidence of severe rash/acne was reported with erlotinib compared with afatinib (grade-3 rash/acne: 10% vs. 6%).

Non–small-cell lung cancer (NSCLC) is the most common form of lung cancer, comprising over 85% of lung cancer cases. SCC develops in the cells lining the airways and represents approximately 30% of NSCLC cases. SCC of the lung is associated with a poor prognosis and limited survival. The median overall survival after a diagnosis of advanced SCC is approximately 1 year.

Afatinib, an oral, once-daily epidermal growth factor receptor (EGFR)-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC. In the U.S., afatinib is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

Source: Boehringer Ingelheim; August 25, 2015.

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