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Astellas Announces FDA Approval of VYLOY™ (Zolbetuximab) as First CLDN18.2-Targeted Therapy for Advanced Gastric and GEJ Cancers

NextEdge Admin

19 Oct 2024

2 min 38 sec

Astellas Pharma announced that the U.S. FDA has approved VYLOY™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express CLDN18.2. This marks VYLOY as the first and only CLDN18.2-targeted therapy approved in the U.S.

The approval is based on positive results from the Phase 3 SPOTLIGHT and GLOW trials, which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with VYLOY plus chemotherapy compared to placebo plus chemotherapy. The SPOTLIGHT trial evaluated VYLOY with mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil), while the GLOW trial assessed VYLOY with CAPOX (capecitabine and oxaliplatin). The most common treatment-emergent adverse events (TEAEs) reported were nausea, vomiting, and decreased appetite.

About 38% of patients screened in these trials had CLDN18.2-positive tumors, which are identified using the VENTANA® CLDN18 (43-14A) RxDx Assay from Roche, an FDA-approved immunohistochemistry (IHC) companion diagnostic. CLDN18.2 positivity is defined by ≥75% of tumor cells showing moderate to strong staining.

Dr. Moitreyee Chatterjee-Kishore, Senior VP of Immuno-Oncology at Astellas, emphasized that VYLOY addresses a critical need in gastric and GEJ cancers, which are often detected in advanced stages. Dr. Samuel Klempner of Massachusetts General Hospital highlighted that VYLOY introduces a novel biomarker-driven treatment, addressing unmet needs for these patients.

Following FDA approval, VYLOY is now available in five global markets: Japan, the UK, the EU, South Korea, and the U.S., with regulatory reviews ongoing in other countries. Testing for CLDN18.2 status is currently offered at multiple U.S. laboratories, with further expansion expected.