Vyloy FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 21, 2024.
FDA Approved: Yes (First approved October 18, 2024)
Brand name: Vyloy
Generic name: zolbetuximab-clzb
Dosage form: Injection
Company: Astellas Pharma US, Inc.
Treatment for: Gastric Cancer
Vyloy (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody used for the combination treatment of patients with HER2-negative gastric cancer or gastroesophageal junction cancer whose tumors are CLDN18.2 positive.
- Vyloy is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 (CLDN18.2) positive as determined by an FDA-approved test.
- Gastric cancer is a cancer of the stomach, and gastroesophageal junction (GEJ) adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach. CLDN18.2 is a transmembrane protein on the cancer cell surface of gastric epithelial cells.
- Vyloy works by binding to CLDN18.2 to induce cancer cell death by activating two distinct immune system pathways: antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
- FDA approval of Vyloy was based on results from the Phase 3 SPOTLIGHT (Vyloy and plus mFOLFOX6 compared to placebo plus mFOLFOX6) and GLOW (Vyloy plus CAPOX compared to placebo plus CAPOX) clinical trials. Both trials met their primary endpoint (progression-free survival) as well as a key secondary endpoint (overall survival) in patients treated with Vyloy plus chemotherapy compared to placebo plus chemotherapy.
-mFOLFOX6 is a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil, and CAPOX is a combination chemotherapy regimen that includes capecitabine and oxaliplatin. - Vyloy is administered by intravenous infusion.
- Warnings and precautions associated with Vyloy include serious hypersensitivity reactions, and severe nausea and vomiting. Patients should be premedicated with antiemetics prior to each infusion.
- Common adverse reactions for Vyloy in combination with mFOLFOX6 or CAPOX include nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.
Common laboratory abnormalities for Vyloy in combination with mFOLFOX6 or CAPOX include decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.
Development timeline for Vyloy
Further information
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