The FDA granted accelerated approval to the monoclonal antibody dostarlimab (Jemperli) for recurrent/advanced endometrial cancer associated with deficient mismatch repair (dMMR).
The approval pertains to patients previously treated with platinum-containing chemotherapy. Targeting the PD-1 receptor, dostarlimab is the seventh member of the anti-PD-1/L1 class to receive FDA approval.
“This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical-need population,” said Richard Pazdur, MD, of the FDA’s Center for Drug Evaluation and Research, in a statement.
Endometrial cancer, the most common gynecologic malignancy in the U.S., is usually diagnosed at an early, typically curable stage. Patients with recurrent or advanced cancer that has progressed during or after chemotherapy have few therapeutic options.
Approximately 25-30% of advanced endometrial cancers exhibit dMMR, and PD-1/L1 inhibitors have demonstrated activity in several tumor types with dMMR.
Primary support for the conditional approval came from a single-arm, multicohort clinical trial involving 71 patients with recurrent or advanced dMMR endometrial cancer. The results showed that 42.3% of the patients responded to dostarlimab, including complete and partial responses; the responses lasted six months or longer in 93% of cases.
Common side effects associated with dostarlimab included fatigue, nausea, diarrhea, anemia, and constipation. Like other drugs in the PD-1/L1 class, dostarlimab can cause immune-mediated side effects, which can be serious in some cases.
The FDA granted the approval to GlaxoSmithKline. In most cases, accelerated approval comes with a requirement for additional studies to provide data supporting the safety and effectiveness of a treatment.