Roche's VENTANA MMR RxDx Panel Gets FDA Approval For Endometrial Cancer

Swiss drug major Roche (RHHBY) announced Friday that the U.S. Food and Drug Administration has approved 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 April 22.

The companion diagnostic test with GSK would help recurrent or advanced endometrial cancer patients with limited treatment options. This can help identify patients who are most likely to benefit from a specific therapy.

Roche noted that VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly).

Endometrial cancer is the most common gynecologic cancer in the U.S. About 90,000 women globally die from endometrial cancer each year.

Roche noted that there are limited treatment options for women whose disease progresses on or after first-line therapy.

This is the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.

The VENTANA MMR RxDx Panel is a label expansion of Roche's current on-market VENTANA MMR IHC Panel.

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