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August 19, 2021updated 22 Nov 2021 2:29pm

US FDA approves Roche’s Ventana panel to identify solid tumour patients

The test helps clinicians to identify patients eligible for GlaxoSmithKline’s Jemperli monotherapy.

Roche has received US Food and Drugs Administration (FDA) approval for its Ventana MMR RxDx panel, a diagnostic test to identify patients whose solid tumours are deficient in DNA mismatch repair (MMR).

The test evaluates a panel of MMR proteins in tumours and detects patients eligible for treatment with GlaxoSmithKline’s (GSK) anti-PD1 immunotherapy Jemperli (dostarlimab-gxly).

MMR is a molecular mechanism that functions to correct some errors that can happen spontaneously during DNA replication. Deficiency in MMR can lead to cancer.

According to the company, around 1.9 million new cancer cases are expected to be diagnosed this year in the US alone.

The FDA approval enables the use of the fully automated panel of MMR biomarkers tested by immunohistochemistry (IHC) and helps clinicians to identify patients who may be eligible for Jemperli immunotherapy.

Roche Diagnostics CEO Thomas Schinecker said: “As the first companion diagnostic of its kind, this test can help qualify patients with solid tumours that are deficient in MMR who have progressed in their disease and who have no other suitable treatment options.

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“Based on the results of our MMR biomarker test, these patients may be eligible to receive GSK’s Jemperli. We are pleased that our innovative companion diagnostic label continues to grow to serve more patients.”

The company stated that MMR deficiency is most common in endometrial cancer as well as other high prevalence dMMR tumour types such as gastric, colorectal, small intestine, cervical and neuroendocrine cancers.

The regulator has recently approved GSK’s Jemperli to treat adult patients with dMMR recurrent or advanced solid tumours.

In April, the VENTANA MMR RxDx Panel was approved by the FDA to identify advanced or recurrent endometrial cancer patients.

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