Jemperli nears first frontline approval for primary advanced or recurrent endometrial cancer

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) alongside chemotherapy for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

If approved in this patient population, the combination of the GSK (LSE: GSK) drug plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.

The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of September 23, 2023. Jemperli also was recently granted Breakthrough Therapy designation for this potential new indication.