Approvals

GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

If the sBLA is approved for this patient population, this could mark the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.

The FDA granted Priority Review to this application as well as assigning a Prescription Drug User Fee Act action date of 23 September 2023.

Currently, Jemperli is approved in the US as a monotherapy in the treatment of dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen. If this sBLA is approved it is likely that the drug could be used earlier in treatment alongside platinum-containing chemotherapy in this patient group.

Hesham Abdullah, senior vice president and global head of Oncology Development at GSK, commented: “We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase 3 RUBY trial. Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, and there is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy. We look forward to working with the FDA and other health authorities as they review this application.”