New lung cancer drug gets EU recommendation27 Feb 2015
European regulators have recommended the approval of Zykadia® (ceritinib) to treat adult patients with a specific genetic mutation in non-small cell lung cancer previously treated with crizotinib.
This recommendation for Zykadia was based on results from two global, multicenter, open-label, single-arm studies.
Treatment for an unmet medical need
Zykadia (ceritinib) is from a new class of medicines known as ALK inhibitors. If approved in the European Union, it will be the first treatment option to address an unmet medical need for patients with ALK+ non-small cell lung cancer, previously treated with another ALK inhibitor, crizotinib (Pfizer's Xalkori). Zykadia is marketed by Novartis and it is already approved in countries such as the United States, Mexico, Chile and South Korea.
The most common adverse reactions were the following:
- liver function test abnormalities
- abdominal pain
- decreased appetite
- kidney function test abnormalities