Astellas Receives FDA Approval for VYLOY™ in Advanced Gastric and GEJ Cancer Treatment
Saturday, October 19, 2024
Astellas Pharma has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-based chemotherapy.
VYLOY™ (zolbetuximab-clzb) is a first-in-class monoclonal antibody that specifically targets and depletes CLDN18.2-positive cells through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, offering a new treatment option for patients with advanced gastric and GEJ cancers.
This treatment is intended for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours test positive for claudin (CLDN) 18.2, using an FDA-approved diagnostic test. VYLOY is the first CLDN18.2-targeted therapy approved in the United States.
The FDA’s approval is supported by data from the Phase 3 SPOTLIGHT and GLOW clinical trials, which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with VYLOY combined with chemotherapy compared to chemotherapy alone. Across both trials, CLDN18.2-positive patients showed better outcomes.
In these trials, approximately 38% of the screened patients were CLDN18.2-positive, with positivity defined as 75% or more tumour cells showing moderate to strong immunohistochemical staining for CLDN18.2. The VENTANA® CLDN18 (43-14A) RxDx Assay from Roche was used as the diagnostic test for identifying eligible patients.
Common side effects associated with the use of VYLOY included nausea, vomiting, and decreased appetite.
VYLOY has now been approved for use in multiple markets, including Japan, the UK, the European Union, and South Korea. Further regulatory reviews are underway globally.
The company has included the potential financial impact of this approval in its forecast for the fiscal year ending March 2025.
Source: prnewswire.com
