Agilent Receives FDA Approval for PD-L1 IHC 22C3 as KEYTRUDA Companion Diagnostic
Agilent Technologies (A) announced that it has received U.S. Food and Drug Administration approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction carcinoma who may be eligible for treatment with KEYTRUDA, Merck's (MRK) anti-PD-1 therapy. PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 who may be eligible for treatment with KEYTRUDA. This approval marks the eighth FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. "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."