Summary of Clinical Use

Dostarlimab was granted accelerated FDA approval in April 2021, as a treatment for patients with mismatch repair deficient (dMMR) recurrent/advanced endometrial cancer that has progressed on or following prior platinum-containing chemotherapy. The European Medicines Agency (EMA) also approved its use in April 2021. In August 2021, the FDA approval was expanded to include other types of dMMR solid tumours. The genetic defect must be confirmed with an FDA-approved test.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02715284	Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors	Phase 1 Interventional	Tesaro, Inc.	GARNET Trial: priority review of outcomes from ths study led to accelerated FDA approval in 2021.	1