Specialty Pharma Journal Specialty, Precision & Technology
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the …
Tag Archives: Zykadia
June, 2017
May, 2017
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30 May
Novartis’ Zykadia Granted Expanded Approval for First-Line Treatment of ALK-Positive NSCLC
Basel, May 26, 2017 – Novartis today announced the US Food and Drug Administration (FDA) approved the expanded use of Zykadia® (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. Zykadia …
February, 2017
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23 February
FDA Grants Priority Review to Novartis’ sNDA for its Lung Cancer Drug
Basel, February 23, 2017 – Novartis today announced that the US Food and Drug Administration (FDA) accepted the Company’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) …
May, 2015
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8 May
Novartis’ Zykadia Receives EU Approval for Treatment of Lung Cancer
Novartis’ lung cancer drug gained European approval for treatment of patients with non-small cell lung cancer (NSCLC). The company said that the European Commission (EC) has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC previously treated with crizotinib. The European Union’s (EU) approval of …