Approvals

GSK has announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

The company previously submitted a supplemental Biologics License Application (sBLA) supporting the new indication, which received Priority Review and was approved ahead of its Prescription Drug User Fee Act action date.

This approval means Jemperli is now indicated earlier in the treatment programme along with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.

Hesham Abdullah, senior vice president and global head of Oncology Development at GSK, commented: “Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit. These results and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Wenora Johnson, president of the board of directors of Facing Our Risk of Cancer Empowered (FORCE), added: “The endometrial cancer community is thrilled by today’s news, which changes the treatment paradigm for a population with long-term unmet needs. FORCE is grateful for the many participants and researchers who contributed to this important study. As an endometrial cancer survivor, I know how much this approval offers hope for patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer.”