Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma

Original from: Agilent 

Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s 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 (Combined Positive Score (CPS) ≥ 1) 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.”

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 (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or GEJ adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) who may benefit from treatment with KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) 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 (CPS ≥ 1).

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 (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Source: Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma