FDA approves Vyloy for advanced gastric or gastroesophageal …
2 days ago · Vyloy has become the first and only CLDN18.2-targeted therapy approved in the United States. The approval is based on the phase 3 SPOTLIGHT and GLOW clinical trials, in which approximately 38% of ...
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for …
Oct 18, 2024 · VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive . TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY ...
FDA clears Astellas' Vyloy as first claudin 18.2 cancer drug
4 days ago · The EU has followed Japan and GB in approving Astellas' first-to-market claudin 18.2-targeted therapy Vyloy, clearing it for gastric and gastroesophageal junction (GEJ) cancer. Investigator sites ...
New First-in-Class Drug Approved for Advanced Stomach Cancer
1 day ago · 2 min read. Oct. 24, 2024 – The FDA has approved a new drug called zolbetuximab designed to attack a novel target that’s in a type of stomach cancer. Marketed under the brand name Vyloy, the ...
News | Astellas Pharma Inc.
Oct 21, 2024. TOKYO, Oct. 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY TM (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults ...
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA
Oct 18, 2024 · VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive . TOKYO, Oct ...
FDA approves Astellas’ VYLOY for gastric cancer treatment
4 days ago · Astellas Pharma has gained approval from the US Food and Drug Administration (FDA) for VYLOY (zolbetuximab-clzb), in conjunction with chemotherapy, for the treatment of advanced gastric and gastroesophageal junction (GEJ) cancer. This is the first US approval for VYLOY, a therapy targeting claudin (CLDN)-18.2-positive tumours identified through ...
FDA Approves Vyloy for Advanced Gastric or Gastroesophageal …
Vyloy becomes the first and only CLDN18.2-targeted therapy approved in the United States. The approval is based on the phase 3 SPOTLIGHT and GLOW clinical trials, in which approximately 38 percent of screened patients had tumors that were CLDN18.2-positive (defined as ≥75 percent of tumor cells demonstrating moderate-to-strong membranous ...
Astellas’ VYLOY™ (zolbetuximab-clzb) Approved by U.S ... - BioSpace
Oct 18, 2024 · VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive . TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY ...
FDA Approves Astellas' Vyloy, Chemo in First-Line CLDN18.2 …
Oct 18, 2024 · The SPOTLIGHT trial explored Vyloy with the fluoropyrimidine-containing chemo mFOLFOX6 versus mFOLFOX6 chemo alone. The median progression-free survival was 10.6 months in the Vyloy arm and 8.7 months in the chemo-only arm. Median overall survival was 18.2 months on Vyloy-chemo versus 15.5 months on chemo alone.
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