Agilent Technologies Inc. announced its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has received European IVDR certification for the use as a Companion Diagnostic (CDx) to aid in the identification of gastric or gastroesophageal Junction (GEJ) adenocarcinoma patients who may be eligible for treatment with KEYTRUDA®? (pembrolizumab)1. PD-L1 IHC22C3 pharmDx (Code SK006) is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada).
In addition to gastric or GEJ adenocarcinoma, PD-L1 I HC 22C3 pharmDx is IVDR certified as an aid in identifying non-small cell lung cancer (NSCLC), urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and cervical cancer patients for treatment with KEYTRU DA. Consequently, PD-L1 IHC 21C3 pharmDx is labeled for seven cancer indications and is the only IVDR-certified CDx to identify gastric and GEJ adenocarc inoma patients for treatment with KEYTR UDA.astric cancer is a leading cause of cancer-related mortality worldwide. In Europe, gastric adenocarcinoma Inc. typically diagnosed at an advanced stage, has a 5-year survival rate of 26%.
In 2022, more than 130,000 Europeans were diagnosed with gastric cancer. In Europe, KEYTRUDA, in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ Adenocarcinoma whose tumors express PD-L1 (CPS 1). Furthermore, KEYTRUDA, In combination with fluoropyrimidine and platinum-containing chemotherapy, are indicated for the first-linetreatment of patients with locally advanced unre intersectable or metastatic HER2 -negative gastric or GEJ adENocarcinoma whose tumors expressed PD-L1 (C PS 1).
PD-L1 IHC 23C3 pharmDx was developed by Agilent in partnership with Merck (known as MS D outside the United States and Canada) as a companion diagnostic for KEYTRUDA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
