Roche PMA Approved for Zykadia Companion Diagnostic

FDA has approved a Roche PMA for its 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 treatment with Novartis’ Zykadia (ceritinib). The agency 5/30 approved the expanded use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with metastatic NSCLC whose tumors are ALK-positive. Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib.

Roche’s assay is available for use on BenchMark IHC/ISH instruments. It is intended for the qualitative detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with Xalkori (crizotinib) or Zykadia.