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NEW YORK – The US Food and Drug Administration on Friday granted accelerated approval to pembrolizumab (Merck's Keytruda) plus chemotherapy as a treatment for locally recurrent, unresectable, or metastatic triple-negative breast cancer patients with high PD-L1-expressing tumors.

Advanced TNBC patients must have a PD-L1 combined positive score of at least 10, as determined by an FDA-approved test, in order to receive the drug. On the same day, the agency also approved Agilent/Dako's PD-L1 IHC 22C3 pharmDx test as a companion diagnostic to identify those with PD-L1-high TNBC.

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