This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a decision by June 21, 2024, while regulatory authorities in Australia, Brazil, Canada, Israel, and Singapore are also evaluating the application under Project Orbis.
This submission is supported by promising early results from a Phase III study, which demonstrated that a combination of Keytruda and chemotherapy significantly reduced the risk of disease progression or death by 46% in mismatch repair proficient (pMMR) cancers and by 70% in deficient (dMMR) cancers when compared to chemotherapy alone.
Keytruda is already approved in the U.S. for advanced endometrial carcinoma that is pMMR and has progressed following systemic therapy, as well as for advanced endometrial carcinoma characterized by high microsatellite instability (MSI-H) or dMMR that has similarly advanced post-systemic treatment. The drug is also under investigation for use in first-line treatment for advanced or recurrent dMMR disease, as well as in the adjuvant setting.- Flcube.com
