FDA approves Jemperli plus chemo in endometrial cancer

Endometrial cancer

GSK’s Jemperli (dostarlimab) has been approved in the US plus chemotherapy as the first new frontline treatment option in decades for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The US Food and Drug Administration (FDA) approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent.

In the RUBY Phase III clinical 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.

The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.

“As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients.”

With this approval, Jemperli is now indicated earlier in treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.

The drug is already approved in the US as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

Matthew Powell, Chief, Division of Gynecologic Oncology, Washington University School of Medicine, and US principal investigator of the RUBY trial said: “As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who have had limited treatment options. Based on the results from the RUBY clinical trial, I look forward to the addition of Jemperli to chemotherapy becoming a new standard of care for patients.”

Edited by: Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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