An anti-programmed death receptor-1 (PD-1) therapy, Keytruda increases the ability of the immune system in the body for detecting and fighting tumour cells.
It works by blocking the interaction between PD-1 with its ligands, PD-L1 and PD-L2, to activate T lymphocytes.
The monoclonal antibody is approved for use as a single agent to treat microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial carcinoma patients.
These patients have disease progression after systemic therapy in any setting and are not eligible for curative surgery or radiation.
The regulatory approval was based on the results obtained from Cohorts D and K of the KEYNOTE-158 trial, which was conducted in 90 participants.
In this study, participants who received Keytruda reported 46% of objective response rate (ORR), 12% of complete response rate, and 33% of partial response rate.
Merck Research Laboratories clinical research vice-president Dr Scot Ebbinghaus said: “This FDA approval is great news for women facing advanced endometrial cancer.
“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.
“We remain committed to pursuing meaningful advances in gynecologic and breast cancers through our portfolio of medicines.”
The company stated that the FDA approval marks second indication for the therapy in endometrial cancer.
The anti-PD-1 therapy has already been approved in combination with lenvima (lenvatinib) for advanced endometrial carcinoma patients.