Tuesday, April 29, 2014

FDA approves Zykadia for late-stage lung cancer

CANCER DIGEST – April 29, 2014 – The U.S. FDA today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

The approval covers patients with tumors that overexpress anaplastic lymphoma kinase (ALK) and have progressed during or after treatment with crizotinib (Xalkori). Zykadia was shown to be highly active in these so called, ALK-rearranged non-small cell lung cancers. Its safety and effectiveness were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. All participants were treated with Zykadia. Results showed that about half of the participants had their tumors shrink, and this effect lasted an average of about seven months.

Although NSCLC accounts for about 85 percent of lung cancer, the ALK-positive subset makes up 2 percent to 7 percent of NSCLC.

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