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Merck’s Keytruda receives FDA approval for advanced endometrial cancer

The approval was based on new data from the KEYNOTE-158 trial


Merck & Co – known as MSD outside the US and Canada – has announced that Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) for advanced endometrial cancer.

The drug can be used for patients with advanced endometrial carcinoma whose disease has progressed despite prior treatment, and who are not candidates for curative surgery or radiation.

The approval was based on new data from the KEYNOTE-158 trial, with 90 patients with unresectable or metastatic endometrial carcinoma being enrolled.

The trial results showed that patients receiving Keytruda demonstrated an objective response rate of 46%. The FDA’s approval marks the fourth gynaecologic cancer indication for Keytruda.

Endometrial cancer is the most common type of uterine cancer. It is estimated that there will be more than 65,000 new cases of uterine cancer and more than 12,500 deaths in the US from the disease in 2022.

Dr David O’Malley, division of gynaecologic oncology at The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, said: “New data from the KEYNOTE-158 trial showed an objective response rate of 46% for certain patients with advanced endometrial carcinoma … treated with Keytruda.”

He added: “The objective response rate and duration of response observed in this trial solidify the role of Keytruda as a treatment option for these patients.”

Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, commented: “We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda, as monotherapy and in combination, with two approved indications in this area.”

The drug has also been approved in combination with Lenvima (lenvatinib) to treat patients with advanced endometrial carcinoma.

Article by
Fleur Jeffries

22nd March 2022

From: Regulatory



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