- The FDA has approved Roche Holdings AG's RHHBY Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer Inc's (NYSE: PFE) Lorbrena (lorlatinib).
- The assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue.
- It is indicated as an aid in identifying patients eligible for treatment with PFE's Xalkori (crizotinib), Novartis AG's (NYSE: NVS) Zykadia (ceritinib), Roche's Alecensa (alectinib), or Lorbrena in the U.S.
- Price Action: RHHBY shares closed 1.2% lower at $40.12 on Monday.
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