PD-L1 IHC 22C3 pharmDx Gets FDA Approval as Companion Diagnostic for Pembrolizumab in Breast Cancer


PD-L1 IHC 22C3 pharmDx will aid in the identification of patients with triple-negative breast cancer eligible for treatment with pembrolizumab.

The FDA has approved the PD-L1 IHC 22C3 pharmDx to aid in the identification of patients with triple-negative breast cancer (TNBC) who are eligible to receive the PD-1 inhibitor pembrolizumab (Keytruda), according to an announcement from Agilent Technologies, Inc.1 Previously, the test had also been approved to identify PD-L1 positivity in patients with non—small cell lung cancer, gastric or gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma to determine eligibility for treatment with pembrolizumab.

This is the only companion diagnostic to receive FDA approval for use in the identification of patients with TNBC who should receive treatment with pembrolizumab plus chemotherapy, according to Agilent Technologies, Inc.

“Anti-PD-1 therapies, including [pembrolizumab], continue to offer new treatment options for a growing population of [patients with] cancer,” Nina Green, vice president and general manager of Companion Diagnostics at Agilent, “With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in TNBC, physicians will be able to access critical information to qualify even more patients who could benefit from these treatments. This new approval reinforces Agilent’s role as a worldwide leader in developing companion diagnostics for targeted therapies.”

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