Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

March 9, 2021 Auto Bot approval, FDA, receives, regulatory, Roche, Treatment 0

Shots:

  • The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib)
  • The label expansion approval strengthens Roche’s commitment to personalized healthcare by providing lung cancer patients with access to more treatment options
  • The Ventana ALK (D5F3) CDx assay is now FDA approved as a CDx in four targeted treatments – Xalkori (crizotinib), Zykadia (ceritinib), Alecensa (alectinib) and Lorbrena (lorlatinib). The assay is the only IHC approved by the FDA as a CDx for Lorbrena

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Yale University

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