FDA Approves Keytruda-chemo Combo for Advanced TNBC Positive for PD-L1

FDA Approves Keytruda-chemo Combo for Advanced TNBC Positive for PD-L1
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), in combination with chemotherapy, to treat people with advanced triple-negative breast cancer (TNBC) and at least 10% of tumor cells positive for PD-L1. The indication includes patients with locally recurrent and inoperable or metastatic tumors, not previously treated with chemotherapy. Tumor PD-L1 status will be determined by the PD-L1 IHC 22C3 pharmDx test (marketed by Dako, a subsidiary of Agilent), which was approved simultaneously by the FDA as a companion diagnostic to identify patients eligible for the combination therapy. This accelerated approval comes less than four months after the FDA granted priority review to Merck’s sup
Subscribe or to access all post and page content.