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FDA Broadens Ceritinib Indication
FDA news release; 2017 May 26
The FDA has had approved Zykadia (ceritinib) for patients with metastatic non-small cell lung cancer (NSCLC).
Indications: Zykadia is a kinase inhibitor indicated for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase-positive.
Dosage and administration: 750 mg orally once daily.
Efficacy and safety: Approval is based on data from ASCEND-4, in which patients taking the drug experienced improved progression-free survival and overall response rate, as well as longer median response duration.
Side effects/risks: The most common adverse reactions are diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, and weight loss.
FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC. [news release]. Silver Spring, MD: FDA. May 26, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560873.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 3, 2017.
Zykadia [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. 2017. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/zykadia.pdf. Accessed June 3, 2017.
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