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April 26, 2021updated 22 Nov 2021 2:29pm

FDA approves Roche’s CDx for endometrial cancer detection

The US Food and Drug Administration (FDA) has granted approval to Roche’s VENTANA MMR RxDx Panel as a companion diagnostic (CDx) to identify advanced or recurrent endometrial cancer patients. 

The US Food and Drug Administration (FDA) has granted approval to Roche’s VENTANA MMR RxDx Panel as a companion diagnostic (CDx) to identify advanced or recurrent endometrial cancer patients.

The panel is a qualitative immunohistochemistry test indicated for analysing mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy.

MMR is a molecular mechanism that works to rectify some errors that can spontaneously happen during DNA replication.

This test can detect patients eligible for treatment with GlaxoSmithKline’s (GSK) anti-PD1 immunotherapy Jemperli (dostarlimab-gxly).

The FDA approved Jemperli based on its biologics license application (BLA) for endometrial cancer last week.

Roche noted that this panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with Jemperli.

Roche diagnostics CEO Thomas Schinecker said: “We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options.

“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.”

The partnership between Roche and GSK signifies a crucial step towards a customised healthcare strategy that can aid in detecting patients who could benefit from a specific treatment.

This CDx will offer clinicians a standardised testing option that utilises a comprehensive panel of DNA MMR biomarkers tested by immunohistochemistry.

Jemperli is indicated for treating mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer patients who have progressed on or have received prior platinum-containing regimen treatment.

MMR deficiency is the most common endometrial cancer and there exist fewer treatment options for women whose disease advances on or after first-line therapy.

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