Novartis has received approval from the European Commission for its Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Zykadia is an oral and selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal fusion protein that promotes the development and growth of certain tumors in cancers including NSCLC.
The approval allows the company to market the drug in all 28 European Union (EU) states, as well as Iceland, Norway and Liechtenstein.
Novartis oncology president Bruno Strigini said: "The approval of Zykadia in the European Union is significant for ALK+ NSCLC patients who have exhausted the other treatment options for their disease.
"This approval is yet another example of our commitment to precision oncology and our continued focus on developing treatment approaches that target specific genetic and molecular characteristics of cancer."
The approval was based on data from two global, multicentre, open-label and single-arm studies, including study A or ASCEND-1 and study B or ASCEND-2.
According to the company, the study A data demonstrated patients with ALK+ NSCLC who received Zykadia 750mg daily after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate (ORR) of 56.4%.
Results of the study B are expected to be released at an upcoming medical congress.
In February 2015, the drug received positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Zykadia also secured approval in the US and other countries within North America, South America, Central America and Asia.
Image: Novartis AG headquarters in Basel. Photo: courtesy of Andrew.