Roche has obtained the US Food and Drug Administration (FDA) approval for VENTANA MMR RxDx Panel as a companion diagnostic test to help identify people with solid tumours.
The test has been indicated to identify DNA mismatch repair (MMR) deficient solid tumours in patients, who may be eligible for receiving GSK’s anti-PD-1 immunotherapy Jemperli.
MMR is a natural mechanism that scans DNA, in order to correct the errors that may cause diseases, and if the MMR is deficient (dMMR), cells mutate leading to cancer.
The US health regulator has granted an accelerated approval for the indication, based on tumour response rate and durability of response.
Roche said that a continued approval for the indication is expected, subject to verification and description of the clinical benefit in confirmatory trials.
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.
“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 VENTANA MMR RxDx Panel is a label expansion of the Roche’s currently commercially available VENTANA MMR IHC Panel.
It evaluates the expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue to determine which solid tumour patients may benefit from GSK’s Jemperli.
The FDA approval enables VENTANA MMR RxDx Panel to provide clinicians with access to a fully automated panel of MMR biomarkers tested by immunohistochemistry (IHC).
Recently, GSK has secured the US FDA approval for its Jemperli to treat dMMR recurrent or advanced solid tumours in adults, as determined by an FDA-approved test.
In April this year, the US FDA has approved VENTANA MMR RxDx Panel along with Jemperli for use in endometrial cancer.
