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Agilent Obtains Expanded FDA Approval For PD-L1 IHC 22C3 PharmDx In Triple-Negative Breast Cancer

Agilent Technologies Inc. (A) said that 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 for treatment with KEYTRUDA or pembrolizumab.

The announcement marked the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the U.S.

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, the company said in a statement.

KEYTRUDA, in combination with chemotherapy, is approved for patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 as determined by an FDA-approved test.

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