Releasing the Brakes on the Immune System Against Solid Tumors 

The U.S. FDA granted accelerated approval to an immunotherapeutic and a companion diagnostic test to treat certain cancer patients whose tumors have a specific biomarker.   

The U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli) for certain adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors. In addition, the agency approved a companion diagnostic to select patients with dMMR tumors for treatment with dostarlimab-gxly. 

The FDA decision was based on an open-label, multicenter clinical trial of patients with dMMR recurrent or advanced solid tumors who progressed following systemic therapy and had no satisfactory alternative treatment. The overall response rate of dostarlimab-gxly was 41.6 percent, with a 9.1 percent complete response rate and a median response duration of 34.7 months.  

Dostarlimab-gxly is in a class of cancer immunotherapeutics known as immune checkpoint inhibitors that release the brakes on cancer-fighting immune cells called T cells. This immunotherapy targets the protein PD-1, which acts like a brake on the T cells.

The VENTANA MMR RxDx Panel was approved by the FDA to identify patients with dMMR tumors who can be treated with dostarlimab. 

Dostarlimab-gxly was granted accelerated approval by the FDA on August 17, 2021. Accelerated approval means continued approval may be contingent upon a confirmatory trial.