FDA and the European Medicines Agency accepted regulatory applications for Gilotrif (afatinib), sponsored by Boehringer Ingelheim, for the treatment of advanced squamous cell carcinoma of the lung, after treatment with first-line chemotherapy.
Gilotrif has also been granted Orphan Drug Designation by the FDA.
The submissions are based on positive data from the phase III LUX-Lung 8 study that showed a significant delay in progression of lung cancer and a significant improvement in overall survival for Gilotrif compared to Tarceva (erlotinib).
Data from LUX-Lung 8 showed that treatment with Gilotrif resulted in superior progression-free survival, reducing the risk of cancer progression by 19 percent, and superior overall survival, reducing the risk of death by 19 percent, compared to Tarceva in this patient population.
More patients had improved overall health-related quality-of-life with Gilotrif than with Tarceva (36 vs. 28 percent). Significantly more patients had an improvement in cough with Gilotrif than with Tarceva (43 vs. 35 percent).
Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names Gilotrif and Giotrif). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumor growth when compared to standard chemotherapy.
In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions) compared to chemotherapy.
