FDA Will Review Two New Applications Seeking Keytruda Approval for TNBC

FDA Will Review Two New Applications Seeking Keytruda Approval for TNBC
The U.S. Food and Drug Administration (FDA) has accepted to review two new Merck applications requesting the approval of Keytruda (pembrolizumab) for the treatment of patients with different forms of triple-negative breast cancer (TNBC). One of the two supplemental biologics license applications (sBLAs) was granted priority review, which speeds FDA action, with a Prescription Drug User Fee Act (PDUFA). That means the U.S. regulatory agency will make a decision by that date on whether to approve Keytruda, in combination with chemotherapy, as a treatment for TNBC. Specifically, the combo therapy would be used in this indication to treat people with inoperable (locally recurrent unresectable) or metastatic TNBC, whose tumors have at least 10% of cells producing the PD-L1 protein. The second sBLA, which was accepted for standard review, is requesting the approval of a neoadjuv
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