Roche’s VENTANA MMR RxDx Panel is said to be the first companion diagnostic test to identify patients with solid tumours who may benefit from GSK’s Jemperli
Roche’s VENTANA MMR RxDx Panel approved in US. (Credit: Belova59 from Pixabay.)
Roche has secured the US Food and Drug Administration (FDA) approval for its VENTANA MMR RxDx Panel as a companion diagnostic to identify patients with solid tumours.
The US FDA indicated the test to identify DNA mismatch repair (MMR) deficient solid tumours in patients, who may be eligible to receive GSK’s Jemperli.
MMR is a natural mechanism that scans DNA to correct the errors that may cause diseases, and if the MMR is deficient (dMMR), cells mutate leading to cancer.
The VENTANA MMR RxDx Panel is a label expansion of Roche’s currently marketed VENTANA MMR IHC Panel and works on BenchMark ULTRA instrument.
Roche claimed that its VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR),
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.”
GSK’s Jemperli is an anti-programmed death receptor-1 (PD-1) antibody that works by binding with the PD-1 receptor and blocks its interaction with the PD-L1 and PD-L2 ligands.
The immunotherapy was granted EC approval to treat mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer in women, in April this year.
Jemperli was also approved by the US FDA to treat mismatch repair-deficient (dMMR) advanced endometrial cancer in adults.
Along with Jemperli, the US regulatory agency has also approved VENTANA MMR RxDx Panel to identify patients with endometrial cancer who may be eligible for Jemperli therapy.
Recently, the US FDA has approved the drug to treat dMMR recurrent or advanced solid tumours in adult patients, as determined by an FDA-approved test.