FDA Approves Agilent's PD-L1 Companion Diagnostic for Esophageal Cancer
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
Agilent Technologies has received U.S. Food and Drug Administration approval for its 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 (pembrolizumab), Merck's anti-PD-1 therapy. This approval marks the eighth FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.
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 (Combined Positive Score ≥ 1) who may be eligible for treatment with KEYTRUDA. The test enables identification of patients whose tumors express PD-L1 for potential treatment with the immunotherapy.
In addition to esophageal or GEJ carcinoma, PD-L1 IHC 22C3 pharmDx, Code SK006, is also indicated to help 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 treatment with KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1. In 2025, esophageal cancer caused approximately 16,250 deaths in the United States, with a 5-year relative survival rate of 21.9 percent.
PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck as a companion diagnostic for KEYTRUDA. The company's vice-president and general manager of the Clinical Diagnostics Division stated that 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.