CHMP positive recommendation for dostarlimab for women with recurrent or advanced endometrial cancer.- GSK

GlaxoSmithKline (GSK) plc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending dostarlimab, an anti-programmed death-1 (PD-1) monoclonal antibody, for use as monotherapy 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. The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. The application is based on data from the GARNET study, which represents the largest dataset of an anti-PD-1 monotherapy treatment in endometrial cancer. Data from the GARNET study were initially presented at the 2019 Society for the Gynecologic Oncology (SGO) Annual Meeting, and updated data were presented at the 2020 SGO Annual Meeting and the European Society for Medical Oncology (ESMO) Virtual Congress 2020.. Dostarlimab is under review with the FDA for the treatment of women with recurrent or advanced endometrial cancer who have progressed on or following platinum-based chemotherapy and whose tumours are dMMR. It is also under FDA review for the treatment of adult patients with dMMR recurrent or advanced solid tumours. Dostarlimab is not currently approved for use anywhere in the world.