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Roche Nabs FDA Label Expansion for Ventana CDx Panel

NEW YORK – Roche announced on Thursday that it has received approval from the US Food and Drug Administration for a label expansion of its Ventana MMR RxDx Panel to determine which solid tumor patients could benefit from treatment with Merck's Keytruda (pembrolizumab).

The immunohistochemistry companion diagnostic test is intended to identify patients with solid tumors that are deficient in DNA mismatch repair (dMMR), as well as patients with endometrial cancer whose tumors are proficient in DNA mismatch repair (pMMR) that might be eligible for a combination treatment with Keytruda and Merck's Lenvima (lenvatinib). 

The test evaluates a panel of MMR biomarkers in formalin-fixed, paraffin-embedded tumor tissue. It was originally approved by the FDA in April 2021 to identify endometrial carcinoma patients eligible for treatment with GlaxoSmithKline's Jemperli (dostarlimab-gxly). In August 2021 the label was expanded to include dMMR solid tumor patients, and in March 2022 the label was again expanded to include dMMR solid tumor patients for treatment with Keytruda.