FDA Expands Approval of Roche’s Ventana MMR RxDx Panel

The FDA has expanded its approval of Roche’s Ventana MMR RxDx test for identifying patients with solid tumors with deficient mismatch repair (dMMR) genes and patients with proficient mismatch repair (pMMR) endometrial cancer who are eligible for treatment with Merck’s blockbuster cancer drug Keytruda (pembrolizumab).

The Ventana test also assesses pMMR endometrial cancer patients for both Keytruda and Eisai’s Lenvima (lenvatinib) as a potential treatment combination.

The diagnostic test first received FDA approval in April 2021 to assess the eligibility of patients with endometrial cancer for treatment with GSK’s Jemperli (dostarlimab-gxly).