CHMP recommends Keytruda + chemo for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer. Merck Inc.,
The positive opinion is based on progression-free survival (PFS) and overall survival (OS) results from the Phase III KEYNOTE-355 trial, which showed that treatment with Keytruda in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as compared to chemotherapy alone, significantly improved PFS and OS in these patients. Overall survival data from KEYNOTE-355 will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 on Sept. 19. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union..
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