Roche Receives FDA Approval for VENTANA MMR RxDx Panel to Identify dMMR Solid Tumour Patients and pMMR Endometrial Cancer Patients Eligible for KEYTRUDA
Roche (SIX: RO, ROG;OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of a label expansion for the VENTANA MMR RxDx Panel. This approval advances the company’s commitment to personalised healthcare through tests that determine which patients are most likely to respond to specific and targeted therapies.
The VENTANA MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and who may be eligible for KEYTRUDA® (pembrolizumab). The panel is also the first companion diagnostic test to aid in identifying endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR), and who may be eligible for a combination of KEYTRUDA and the tyrosine kinase inhibitor (TKI) LENVIMA® (lenvatinib). The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.
“Roche is committed to advancing personalised healthcare options for all solid tumour patients,” said Jill German, Head of Pathology, Roche Diagnostics. “As the first companion diagnostic of its kind, our test provides patients with access to multiple therapies, enabling targeted treatment. We are pleased that our innovative companion diagnostic portfolio continues to grow to serve more patients.”
MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient (dMMR), cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high-prevalence dMMR tumour types include gastric, colorectal, small intestine, cervical and neuroendocrine cancers. In the US, prevalence of dMMR across patients with solid tumours has been estimated at 14 percent.1 PD-1 inhibitors can be an effective treatment in cancers with MMR deficiency. For endometrial cancer patients without this MMR deficiency (pMMR) PD-1 inhibitors may retain activity when combined with a tyrosine kinase inhibitor (TKI).
FDA approval of the label expansion for the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by IHC. This label expansion follows the April 2021 FDA approval of the VENTANA MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy JEMPERLI® (dostarlimab-gxly). That approval was expanded for the following indications on the dates below:
- August 2021 – dMMR solid tumour patients for treatment with JEMPERLI
- March 2022 – dMMR solid tumour patients for treatment with KEYTRUDA
- June 2022 – pMMR solid tumour patients for treatment with a combination of KEYTRUDA and LENVIMA
Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.2, 3 Endometrial cancer is the most common gynaecological cancer in the U.S. and the fourth most common cancer in women in North America.4