FDA approves zolbetuximab-clzb with chemotherapy
On October 18, 2024, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.) with fluoropyrimidine- and platinum-containing chemotherapy for gastric or gastroesophageal …
Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2 …
2023年5月20日 · Zolbetuximab, a monoclonal antibody targeting claudin-18 isoform 2 (CLDN18.2), has shown efficacy in patients with CLDN18.2-positive, human epidermal growth …
FDA Approves Zolbetuximab Plus Chemo for CLDN18.2+ Gastric …
2024年10月18日 · GLOW trial demonstrated enhanced PFS and OS with zolbetuximab and CAPOX versus placebo, confirming its efficacy. The FDA approved zolbetuximab plus …
Vyloy (zolbetuximab) : Uses, Dosage, Side Effects, Warnings - Drugs.com
2024年10月30日 · Vyloy (zolbetuximab) is a new cancer medicine used for gastric cancer and gastroesophageal junction cancer (GEJ), it targets a protein called Claudin 18.2 on cancer …
New First-in-Class Drug Approved for Advanced Stomach Cancer
2024年10月24日 · The FDA has approved a new drug called zolbetuximab designed to attack a novel target that’s in a type of stomach cancer.
FDA Acknowledges BLA of Zolbetuximab in HER2 ... - Targeted …
2024年5月31日 · The FDA has acknowledged the resubmitted biologics license application (BLA) for zolbetuximab (Vyloy) as a first-line treatment for locally advanced unresectable or …
Zolbetuximab in Gastric or Gastroesophageal Junction …
2024年9月16日 · The addition of zolbetuximab, an anti–claudin 18.2 antibody, to chemotherapy in gastric and gastroesophageal junction adenocarcinoma led to longer progression-free and …
Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or
2023年7月31日 · GLOW (closed enrollment), a global, double-blind, phase 3 study, examined zolbetuximab, a monoclonal antibody that targets CLDN18.2, plus capecitabine and oxaliplatin …
Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab …
2023年7月6日 · Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb) that targets and binds to Claudin 18.2 (CLDN18.2), a transmembrane protein. …
Claudin 18.2 as a novel therapeutic target - Nature
2024年3月19日 · In the phase III SPOTLIGHT and GLOW trials, zolbetuximab, an anti-claudin 18.2 monoclonal antibody, has been shown to improve OS and progression-free survival …
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