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FDA approves PD-L1 IHC 22C3 pharmDx as aid in identifying triple-negative breast cancer.- Agilent Technologies

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Published:15th Nov 2020
Agilent Technologies announced it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with Keytruda (pembrolizumab). PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as Keytruda. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with Keytruda. Keytruda, in combination with chemotherapy, is approved for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) at least 10] as determined by an FDA-approved test. PD-L1 IHC 22C3 pharmDx is the only companion diagnostic that is FDA-approved to aid in the identification of TNBC patients for treatment with Keytruda in combination with chemotherapy.
Condition: Breast Cancer Triple Neg
Type: drug

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