GSK: FDA priority review for endometrial cancer drug

(CercleFinance.com) - The US FDA has accepted for priority review GSK's application to expand the indication for Jemperli (dostarlimab) in combination with chemotherapy to include all adult patients with advanced or recurrent primary endometrial cancer.


The FDA has set an action date of 23 August 2024 on prescription drug user fees.

The combination of dostarlimab and chemotherapy is the only immuno-oncology-based treatment to show a statistically significant and clinically meaningful survival benefit in the overall patient population, it says.

The sBLA is based on the results of part 1 of the phase III RUBY trial. The trial met its primary endpoints of progression-free survival (PFS) and overall survival (OS).

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynecological cancer in developed countries, with around 417,000 new cases reported worldwide each year, and incidence rates are expected to rise by almost 40% between 2020 and 2040.


Copyright (c) 2024 CercleFinance.com. All rights reserved.