Agilent Expands CE-IVD Mark for Companion Dx Tests Alongside BMS European Opdivo Approvals

Original from: 360DX

Agilent Technologies on Tuesday announced it has obtained expanded CE-IVD marking for the use of its PD-L1 IHC 28-8 pharmDx immunohistochemical assay as a companion diagnostic test to guide treatment for newly approved indications for Bristol Myers Squibb's Opdivo. 

Santa Clara, California-based Agilent said it obtained CE marking for the CDx as an aid in identifying esophageal squamous cell carcinoma patients for treatment with Bristol Myers Squibb's PD-1-targeted immunotherapeutic Opdivo (nivolumab), in combination with fluoropyrimidine and platinum-based chemotherapy or with Opdivo in combination with BMS' Yervoy (ipilimumab). 

In a separate announcement, Agilent said it obtained CE marking for PD-L1 IHC 28-8 pharmDx that extends its use to identify patients diagnosed with muscle-invasive urothelial carcinoma who have tumor cell PD-L1 expression of greater than or equal to 1 percent for adjuvant treatment with Opdivo.

Last October, the company said it had received CE-IVD marking for PD-L1 IHC 28-8 pharmDx as a CDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers.

Separately, Bristol Myers Squibb said that the European Commission (EC) has approved Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression of equal to or greater than 1 percent. 

The New York City-based biopharmaceutical company further announced that the EC has approved Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression of equal to or greater than 1 percent who are at a high risk of recurrence after undergoing radical resection. 

The European Commission also approved Opdivo in combination with Yervoy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression of equal to or greater than 1 percent.

Source: Agilent Expands CE-IVD Mark for Companion Dx Tests Alongside BMS European Opdivo Approvals