GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli

May 3, 2021
Pharmaceutical Technology Editors

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

GlaxoSmithKline (GSK) has received approval from both the European Commission (EC) and FDA for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for treating endometrial cancer. The company announced the EC approval on April 23, 2021 and FDA announced its approval on April 22, 2021.

In Europe, the EC approved the biologic for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. This approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe, according to the GSK press release.

The approval in Europe is based on results from a multi-cohort study, in which treatment with dostarlimab resulted in an objective response rate of 43.5% and a disease control rate of 55.6%.

“Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis. [The] approval of dostarlimab means that for the first time in Europe, these women will have access to a new, innovative, and much-needed therapy,” said Hal Barron, MD, chief scientific officer and president R&D, GSK, in the company press release.

Similarly, FDA approved Jemperli 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 (dMMR, which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

Jemperli received priority review designation and breakthrough therapy designation for this indication. The biologic was approved under FDA’s accelerated approval pathway, which allows the agency to 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. The agency stated in its press release that 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.

“Today’s approval of Jemperli is evidence of [FDA’s] progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “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.”

GSK stated in its press release that it is also studying dostarlimab for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer.

Source: GlaxoSmithKline and FDA