FDA has approved pembrolizumab, developed by Merck and marketed under the brand name Keytruda, for treating advanced or recurrent endometrial carcinoma (EC).
The FDA’s decision was based on data from the KEYNOTE-868/NRG-GY018 clinical trial for pembrolizumab, offering hope to patients with EC.
The FDA emphasized the importance of healthcare professionals reporting any severe side effects potentially linked to pembrolizumab for treating EC through the MedWatch Reporting System.
This approval of pembrolizumab for EC reflected the FDA’s collaborative efforts with international regulatory agencies such as Australia’s Therapeutic Goods Administration (TGA), Brazil’s Health Regulatory Agency (ANVISA), Health Canada (HC), and Israel’s Ministry of Health (IMoH).
While the FDA’s review for Pembrolizumab was complete, applications reviewed at these other agencies are ongoing.
Pembrolizumab review benefited from Project Orbis, an initiative by the FDA Oncology Center of Excellence (OCE) that fosters collaboration among international regulatory agencies.
Source: FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-primary-advanced-or-recurrent-endometrial-carcinoma
