NEW YORK ─ Agilent Technologies on Thursday announced it has received the CE-IVD mark of approval for PD-L1 IHC 28-8 pharmDx as a companion diagnostic test to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers.
PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent nivolumab (Opdivo) developed by Bristol Myers Squibb.
"The added indication of PD-L1 IHC 28-8 pharmDx will give physicians in Europe important information to inform first-line treatment decisions for patients with these common and potentially deadly cancers," Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said in a statement.
Santa Clara, California-based Agilent said that when used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, treatment with nivolumab in combination with chemotherapy provides a PD-1-directed treatment to demonstrate superior overall survival and progression-free survival compared to chemotherapy alone. Such treatment is specific to patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score of greater than or equal to 5.
Separately, Bristol Myers Squibb said today the European Commission approved nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma if the tumor expresses PD-L1 with a combined positive score of at least 5.
Last week, Agilent announced that the US Food and Drug Administration had granted approval for Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay as an aid in identifying patients with early breast cancer who are at high risk of disease recurrence and for whom adjuvant treatment with Eli Lilly's abemaciclib (Verzenio) in combination with endocrine therapy is being considered.