U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.
Endometrial cancer is the most common gynecologic malignancy in the United States and its prevalence is increasing. Approximately 75% of endometrial cancers are diagnosed at an early stage and are typically curable with surgery. However, women with advanced and recurrent endometrial cancer have limited therapeutic options following front-line standard treatment with a platinum-containing chemotherapeutic regimen. Approximately 25% to 30% of patients with advanced endometrial cancer have dMMR tumors.
Jemperli works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). Jemperli helps the body’s immune system in its fight against cancer cells by blocking this pathway.
Jemperli received Priority Review designation and Breakthrough Therapy designation for this indication. Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
Jemperli was approved for this new indication using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further clinical trials may be required to verify and describe anticipated clinical benefits of Jemperli and the sponsor is currently conducting these trials in additional patients with dMMR endometrial tumors.
The FDA granted approval to GlaxoSmithKline.