FDA approval for Roche diagnostic solid tumour test

The US Food and Drug Administration (FDA) has approved Roche’s Ventana MMR RxDx Panel, a companion diagnostic test designed to identify patients whose solid tumours are deficient in DNA mismatch repair (MMR) and who may benefit from GSK’s anti-PD-1 immunotherapy treatment Jemperli (dostarlimab-gxly).

Jemperli was approved by the FDA on 17 August for the treatment of adult patients with dMMR recurrent or advanced solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options. The accelerated approval was based on tumour response rate and durability of response.

The Roche test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians. According to Roche, FDA approval of this collaboration with GSK represents an important step towards a personalised healthcare strategy, with the new diagnostic tests determining which patients are suited to specific and targeted therapies.

"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,” said Thomas Schinecker, CEO Roche Diagnostics. “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.”

In April 2021, GSK received US approval for PD-1 inhibitor Jemperli for the treatment of endometrial cancer, following an FDA-approved test. GSK acquired Jemperli as part of its $5.1bn acquisition of cancer specialist Tesaro, although the drug was initially developed by AnaptysBio.