European Commission approves Novartis' lung cancer drug Zykadia

Novartis announced Friday that the European Commission approved Zykadia (ceritinib) to treat adults with ALK-positive advanced non-small-cell lung cancer (NSCLC) previously treated with Pfizer's Xalkori (crizotinib). The company noted that the oral, selective ALK inhibitor is the first drug cleared in Europe for these patients.

The approval, which follows a recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, was based on data from two studies. Results from the ASCEND-1 trial showed that patients with ALK-positive NSCLC who received Zykadia after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate of 56.4 percent. Novartis noted that detailed data from the ASCEND-2 study will be presented at an upcoming medical meeting.

Zykadia is approved in 10 countries outside the EU, including the US and other markets within North America, South America, Central America and Asia. In addition, regulatory filings are under way worldwide.

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