Roche gets USFDA nod for VENTANA FOLR1 RxDx Assay to detect ovarian cancer patients eligible for ELAHERE
Ovarian cancer is the eighth most common cancer in women worldwide and patients often have advanced disease when diagnosed.
Tucson: Roche has announced the US Food and Drug Administration (USFDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine-gynx).
ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by ImmunoGen, Inc., approved under FDA's Accelerated Approval program for the treatment of FRÉ‘-positive platinum-resistant ovarian cancer.
Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRÉ‘), is expressed at some level in approximately 90 percent of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients. The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy.
"We're proud to expand our women's health and oncology portfolios through the addition of the first companion diagnostic IHC test for ovarian cancer," said Jill German, Head of Pathology Lab at Roche Diagnostics. "This test will enable clinicians to make more informed treatment decisions for patients with ovarian cancer by quickly determining whether they qualify for ELAHERE therapy, potentially improving their outcomes."
The approval is based on the results of the SORAYA clinical study. In the study, approximately 35% of ovarian cancer patients expressed high levels of FRα (defined as ≥ 75% tumour cells staining with 2+/3+ intensity) and were considered FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRα-positive patients, about 32 percent demonstrated a partial or complete response to ELAHERE therapy.
Ovarian cancer is the eighth most common cancer in women worldwide and patients often have advanced disease when diagnosed. Despite improvements in primary therapy, mortality rates remain high, and 80 percent of patients with advanced EOC will have their disease recur. The five-year relative survival rate for all stages of invasive EOC is 49 percent.
Read also: Monkeypox: Roche bags USFDA EUA for RT-PCR test cobas MPXV
