FDA Approves Roche Diagnostic for Targeting Gastric and Gastroesophageal Junction Cancer

Roche has recently announced the approval of its VENTANA CLDN18 (43-14A) RxDx Assay by the U.S. Food and Drug Administration (FDA). This marks the first FDA-approved immunohistochemistry (IHC) companion diagnostic for identifying CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. This approval opens new avenues for targeted treatment options for these patients, particularly with Astellas' therapy VYLOY (zolbetuximab).

Jill German, Head of Pathology Lab at Roche Diagnostics, emphasized the significance of this diagnostic tool, noting that patients with gastric or GEJ cancers are often diagnosed at an advanced stage due to the non-specific nature of early symptoms. The VENTANA CLDN18 (43-14A) RxDx Assay aims to identify patients eligible for targeted treatments, providing them with vital therapeutic options and advancing personalized healthcare.

Current medical guidelines recommend the use of biomarkers to guide treatment decisions in gastric and GEJ cancers. The VENTANA CLDN18 (43-14A) RxDx Assay can determine the status of CLDN18.2, a biomarker that predicts the response to targeted therapy. VYLOY is the first FDA-approved treatment aimed at HER2-negative, locally advanced unresectable, or metastatic gastric or GEJ cancer patients whose tumors are CLDN18.2-positive.

Gastric cancer remains a significant health challenge, being the fifth most common cancer and the fourth leading cause of cancer deaths globally. In the United States, the situation is particularly dire, with 62% of gastric/GEJ cancer cases being diagnosed at an advanced stage, contributing to a low five-year overall survival rate of just 6%. Despite being less prevalent in the U.S., gastric/GEJ cancer is often detected late due to its nonspecific symptoms.

The VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical test designed to assess Claudin 18 (CLDN18) protein in gastric and GEJ adenocarcinomas. The test uses the OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument, aiding in identifying patients who may benefit from VYLOY (zolbetuximab) treatment. The assay measures expression of both CLDN18 protein variants, with CLDN18.2 being the more prevalent in gastric and GEJ cancers.

The FDA approval of the VENTANA CLDN18 (43-14A) RxDx Assay is founded on data from the SPOTLIGHT and GLOW clinical studies. These studies utilized the assay to identify patients with CLDN18.2-positive tumors, defined by ≥ 75% of tumor cells showing moderate to strong membrane staining. Approximately 38% of patients in these studies were found to be CLDN18.2 positive. Patients who received a combination of zolbetuximab and chemotherapy showed a 25-31% reduction in disease progression or death.

Roche, founded in 1896, has grown to become the world's largest biotechnology company and a leader in in-vitro diagnostics. Renowned for its commitment to personalized healthcare and scientific excellence, Roche aims to improve and save lives globally. The company collaborates with various stakeholders to combine strengths in diagnostics and pharmaceuticals, aiming to transform healthcare delivery.

Roche's efforts in sustainability and improving healthcare access have been recognized by the Dow Jones Sustainability Indices, naming it one of the most sustainable companies in the pharmaceutical industry for fifteen consecutive years. The company operates globally, with Genentech in the U.S. and as the majority shareholder of Chugai Pharmaceutical in Japan, continuing its mission to provide better healthcare solutions.