FDA approves companion diagnostic for an anti-PD-1 immunotherapy
The U.S. Food and Drug Administration (FDA) has approved Roche’s VENTANA MMR RxDx Panel, a test that aids in identifying patients whose solid tumors are deficient in DNA mismatch repair (MMR).
These patients may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GlaxoSmithKline (GSK).
MMR is a naturally occurring mechanism that scans DNA, correcting errors that cause disease. When MMR is deficient (dMMR), cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high prevalence dMMR tumor types include gastric, colorectal, small intestine, cervical and neuroendocrine cancers, according to Roche. In the U.S., prevalence of dMMR across patients with solid tumors has been estimated at 14%. PD-1 inhibitors can be effective treatment in cancers with MMR deficiency.
JEMPERLI was approved by the FDA on August 17, 2021, for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
