GSK Announces FDA Approval of Jemperli

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In a company press release, GSK revealed the FDA approval of Jemperli for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). With a previous approval as a monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer, Jemperli is now indicated earlier in treatment in combination with chemotherapy.

Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” said Hesham Abdullah, SVP, global head of oncology development, GSK, as per the release. "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.”

Reference: Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer. GSK. July 31, 2023. Accessed August 2, 2023. https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/