The FRα
The FRα test is conducted to facilitate the delivery of mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer who are FRα-positive and have had 1-3 lines of therapy.
On September 19, 2024, the EMA rendered a favorable opinion for the use of mirvetuximab soravtansine in patients with FRα-positive, platinum-resistant ovarian cancer who had undergone 1-3 lines of therapy, as evidenced by the phase III MIRASOL research.Mirvetuximab soravtansine received FDA approval in the US in March 2024.
The assessment of FOLR1 (FRα) is conducted immunohistochemically on biopsy samples, surgical specimens, or tissue embedded in paraffin blocks.The Ventana BenchMark Ultra automated platform is utilized.
In clinical practice, a sample is deemed FOLR1 (FRα) positive if the neoplastic cells exhibit moderate (2+) to intense (3+) complete or incomplete membrane staining in 75% or more of the sample. The sample is deemed acceptable if it contains a minimum of one hundred live cancer cells. A positive external control is employed.
Refer to the EMA Positive Opinion
Evaluate Claudin 18.2
The Claudin 18.2 (CLDN 18.2) test assesses eligibility for Zolbetuximab administration in conjunction with chemotherapy for patients with advanced or metastatic gastric and gastroesophageal junction cancer.
On September 20, the EMA approved Zolbetuximab for patients with HER2 negative/Claudin18.2 positive advanced or metastatic gastric adenocarcinoma and gastroesophageal junction as first-line therapy in conjunction with chemotherapy, based on the phase III GLOW and SPOTLIGHT investigations. Zolbetuximab recently obtained FDA approval in the US on October 18, 2024. Furthermore, recent research concerning Claudin 18.2-positive patients with advanced or metastatic gastric and gastroesophageal junction cancer was showcased at this year’s ESMO (ESMO POSTERS1,2,3).
The Claudin 18.2 biomarker functions as a prognostic indicator in pancreatic cancer. The concept of the phase II randomized GLEAM research was presented at ESMO, investigating the administration of Zolbetuximab in conjunction with chemotherapy for patients with pancreatic cancer. In this study, 27.7% of patients exhibited Claudin 18.2 positive (≥ 75%).
Claudin 18.2 is assessed immunohistochemically on biopsy samples, surgical specimens, or paraffin-embedded tissues for adenocarcinomas of the stomach and gastroesophageal junction. The Ventana BenchMark Ultra platform is utilized in an automated capacity
Recent studies indicate that moderate (2+) to strong (3+) complete or incomplete membrane immunohistochemistry expression in neoplastic cells, with a minimum proportion of 75%, is deemed positive expression. A positive control from an external source is utilized.
