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  • VYLOY® (zolbetuximabclzb) Clinical Trial Results
    VYLOY (zolbetuximab-clzb) was studied in combination with chemotherapy in 2 clinical trials of patients with advanced* stomach or GEJ cancer whose tumors were HER2-negative and claudin 18 2 positive Trial 1 enrolled 565 patients
  • Astellas VYLOY™ (zolbetuximab-clzb) Approved by U. S. FDA for Treatment . . .
    Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting and decreased appetite 2,3 An FDA-approved test is used to identify patients who may be eligible for VYLOY 1 The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved
  • Drug Trials Snapshots: VYLOY - FDA
    DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? VYLOY is a claudin (CLDN) 18 2-directed cytolytic antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy
  • VYLOY® (zolbetuximab-clzb) Official HCP Site
    Learn about VYLOY, used in combination with chemo to treat claudin 18 2 positive, HER2 negative locally advanced unresectable or metastatic gastric GEJ adenocarcinoma (≥1 randomized Phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate
  • Vyloy (zolbetuximab) : Uses, Dosage, Side Effects, Warnings - Drugs. com
    Vyloy is a new cancer medicine used for gastric cancer and gastroesophageal junction cancer, that targets Claudin 18 2 on cancer cells Includes Vyloy side effects, dose, use and more 2024, after positive results from the GLOW clinical trial (NCT03653507) and SPOTLIGHT clinical trial (NCT03504397) In the SPOTLIGHT trial results showed the
  • Vyloy® (zolbetuximab-clzb) - Onco360
    The FDA approval of Vyloy ® is based on the results of the Phase III GLOW and SPOTLIGHT clinical trials In the SPOTLIGHT trial, a median progression free survival (PFS) of 10 61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8 67 months with placebo plus mFOLFOX6
  • FDA Approves Zolbetuximab-clzb with Chemotherapy for Gastric or . . .
    Full prescribing information for Vyloy will be posted on Drugs@FDA Efficacy was evaluated in trials SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) Both were randomized (1:1), double-blind, multicenter trials that enrolled patients with CLDN18 2 positive advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma
  • VYLOY (zolbetuximab-clzb) for injection, for intravenous use VYLOY . . .
    VYLOY is a claudin 18 2-directed cytolytic antibody and is indicated in 6 1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8 1 Pregnancy 8 2 Lactation 8 3 Females and Males of Reproductive Potential 8 4 Pediatric Use 8 5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
  • Astellas VYLOY™ (zolbetuximab-clzb) Approved by U. S. FDA for Treatment . . .
    VYLOY is the first and only CLDN18 2-targeted treatment approved in the U S for adults with advanced gastric and About GLOW Phase 3 Clinical Trial GLOW is a Phase 3, global, multi-center
  • FDA approves Astellas’ VYLOY for gastric cancer treatment
    In the SPOTLIGHT trial, VYLOY was evaluated with mFOLFOX6 In the GLOW study, it was combined with CAPOX The trials showed that 38% of screened patients had CLDN18 2-positive tumours, defined by a specific level of immunohistochemical staining determined by Roche’s assay





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