Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial carcinoma and in combination with chemoradiotherapy (CRT) for the treatment of FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. These indications were previously approved in the United States in June and January of this year.
The new indications are supported by positive results from the Phase III NRG-GY018 trial, also known as KEYNOTE-868, and the Phase III KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047. In the NRG-GY018/KEYNOTE-868 trial, Keytruda combined with carboplatin and paclitaxel, followed by Keytruda as a single agent, showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone. In the KEYNOTE-A18 trial, Keytruda combined with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS compared to concurrent CRT alone for newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer. The drug was found to be safe and tolerable in both studies.- Flcube.com
