Tag: zykadia

February 23, 2017 Off

Novartis’s cancer drug wins FDA’s sNDA, priority review and breakthrough therapy designation

By Dino Mustafić

US Food and Drug Administration (FDA) has accepted Novartis’s supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.