Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

Roche has 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.^[1] In addition, about 90,000 women globally die from endometrial cancer each year.^[2] 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 standardized 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.

References:

Lortet-Tieulent J, J Ferlay, F Bray, and A Jemal. International patterns and trends in endometrial cancer incidence, 1978-2013. J Natl Cancer Inst. (2018) 110, 354-361.

Bray F, Ferlay J, et al, Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. (2018) 68:394–424. 10.3322/caac.21492

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