Drugs and FDA
FDA grants accelerated approval to dostarlimab for dMMR solid tumors
Dostarlimab is approved for adults with dMMR advanced or recurrent solid tumors who have no satisfactory alternative treatment options.
The FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adults with mismatch repair deficient (dMMR) recurrent or advanced solid tumors that progressed on or after prior treatment, when patients have no satisfactory alternative treatment options. The FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic to select patients for treatment.
The approval was based on the GARNET trial, which included 209 patients. The FDA reported an overall response rate of 41.6%, including a 9.1% complete response rate and a 32.5% partial response rate. Median duration of response was 34.7 months (range 2.6, 35.8+). Common adverse reactions included fatigue or asthenia, anemia, diarrhea and nausea. Continued approval may depend on confirmatory trials verifying and describing clinical benefit.
