March 23, 2021—Roche announced FDA approval of the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib).
“This FDA approval is great news for ALK-positive patients,” Jill German, head of Roche pathology customer segment, said in a press statement. “It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy. This label expansion advances Roche’s commitment to personalized health care by providing lung cancer patients with access to more treatment options and a better chance for progression-free survival compared to the standard of care.”
The Ventana ALK (D5F3) CDx assay is intended for the qualitative detection of the anaplastic lymphoma kinase protein in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue stained with a BenchMark Ultra or BenchMark XT immunohistochemistry/in situ hybridization slide staining instrument.