FDA and EMA to Review Boehringer Ingelheim’s Lung Cancer Drug Gilotrif

The FDA and European Medicines Agency have accepted new drug applications for Boehringer Ingelheim’s Gilotrif as a treatment option for patients with advanced squamous cell lung cancer that has progressed after treatment with first-line chemotherapy.

The submissions are based on results of a Phase 3 clinical trial showing a 19 percent reduction both in cancer progression and risk of death in patients who received Gilotrif versus Tarceva (erlotinib).

Gilotrif extended patient survival to a median of 7.9 months, compared to 6.8 months with Tarceva. At the one-year point, 36 percent of patients receiving Gilotrif were still alive, versus 28 percent with Tarceva.

The FDA granted orphan drug designation for Gilotrif on Aug. 3.

Gilotrif, also marketed as Giotrif, has been approved in more than 60 countries to treat metastatic non-small cell lung cancer with specific types of epidermal growth factor receptor mutations. The FDA granted approval for that indication in July 2013. — Jonathon Shacat