ARTICLE | Clinical News

Roche's Ventana approved as companion diagnostic for Novartis' Zykadia

August 4, 2017 7:48 PM UTC

In June, Roche (SIX:ROG; OTCQX:RHHBY) said FDA approved Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients eligible for Zykadia ceritinib (LDK378) from Novartis AG (NYSE:NVS; SIX:NOVN). The assay was already approved as a companion diagnostic for Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) (see BioCentury, June 29, 2015).

Zykadia, an oral small molecule ALK inhibitor, is approved as first-line treatment of metastatic, ALK-positive NSCLC (see BioCentury, June 5)...