Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
- About 90,000 women globally die from endometrial cancer each year1
- VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly)
- Roche/GSK collaboration represents an important step towards a personalised healthcare strategy that can help identify patients who are most likely to benefit from a specific therapy
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.
Endometrial cancer is the most common gynecologic cancer in the U.S. and the fourth most common cancer in women in North America.2 In addition, about 90,000 women globally die from endometrial cancer each year.1 There are limited treatment options for women whose disease progresses on or after first-line therapy and this is the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.
“We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options,” said Thomas Schinecker, CEO of Roche Diagnostics. “This test provides clinicians with an effective tool to identify patients best suited for treatment with GSK’s JEMPERLI, providing a new therapeutic option for women with MMR-deficient endometrial cancer whose disease progresses on or following initial chemotherapy treatment.”
MMR deficiency is most common in endometrial cancer. This companion diagnostic (CDx) provides clinicians with a standardised testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC). FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.
About the VENTANA MMR RxDx Panel
The VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.3,4,5 PD-1 inhibitors can be effective in cancers with a high frequency of MMR deficiency and/or microsatellite-instability, high (MSI-H) including endometrial cancer.3,5 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.
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