Don Murray
The European Medicines Agency (EMA) accepted for review GSK’s (NYSE:GSK) application seeking expanded approval of Jemperli to treat a type of uterus cancer.
The EMA validated the company’s Type 2 Variation for a potential new use of Jemperli (dostarlimab) in combination with chemotherapy to treat adult patients with a type of gynecological cancer known as mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
The EMA’s Committee for Medicinal Products for Human Use will now begin a formal review process.
The filing was backed by interim data from a phase 3 trial called RUBY, results from which were presented in March.
“With this initial filing, we are accelerating the submission of a potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the RUBY phase III trial,” said Hesham Abdullah, senior vice president, global head of Oncology Development, GSK.
The British pharma giant expects a U.S. regulatory filing to occur in H1 2023.
Jemperli was discovered by AnaptysBio (NASDAQ:ANAB) and licensed to Tesaro, now a part of GSK. AnaptysBio has monetized certain commercial milestones and royalties for Jemperli with Sagard Healthcare Royalty Partners.
Endometrial cancer starts in the layer of cells that form the lining (endometrium) of the uterus.