Agilent Technologies has got FDA nod for its new test that helps identify esophageal and gastroesophageal junction (GEJ) cancer patients who may benefit from KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

 

The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatment. This marks the eighth FDA-approved companion diagnostic indication for the test in connection with the therapy.

 

“With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in esophageal or GEJ carcinoma, Agilent is proud to support clinicians in identifying patients eligible for treatment with KEYTRUDA,” said Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. 

 

“This milestone reinforces Agilent’s commitment to advancing precision medicine and underscores its leadership in delivering trusted companion diagnostics that help enable treatment with anti-PD-1 therapies.”

 

Beyond esophageal and GEJ carcinoma, PD-L1 IHC 22C3 pharmDx also helps physicians identify patients with non-small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric or GEJ adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may benefit from KEYTRUDA.