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FDA, Vyloy and gastric
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's website showed on Friday.
Astellas Pharma's VYLOY Receives FDA Approval For Treatment Of Advanced Gastric And GEJ Cancer
Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in
Astellas Pharma's Cancer Drug Vyloy Gets FDA Approval
Astellas Pharma's drug Vyloy was approved for treatment of advanced gastric and gastroesophageal junction cancer by the Food and Drug Administration.
FDA Approves Astellas' Vyloy, Chemo in First-Line CLDN18.2-Positive Gastric Cancer With Roche CDx
Vyloy is the first CLDN18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.
Astellas Pharma Inc.: Astellas' VYLOY (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
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
Novel Targeted Drug Approved for Stomach Cancers
The FDA approved zolbetuximab (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, in combination with chemotherapy for the first-line treatment of adults with advanced HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma,
Merck and Astellas/Pfizer’s bladder cancer combination receives MHRA approval
Keytruda (pembrolizumab) and Astellas/Pfizer’s Padcev (enfortumab vedotin) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a first-line combination treatment for advanced bladder cancer.
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
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™ (zolbetuximab-clzb) 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 (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.
devdiscourse
17h
Health Update: FDA Approvals, CEO Changes, and Vaccine Progress
FDA's approval of Astellas' therapy for gastric cancer, and CVS Health's leadership shuffle as Karen Lynch steps down amid ...
pharmaphorum
2d
Astellas claims EU okay for first claudin 18.2 cancer drug
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.
Vyloy
...
GlobalData on MSN
7d
Roche’s VENTANA CLDN18 assay gains CE mark
"Roche’s VENTANA CLDN18 assay gains CE mark" was originally created and published by Medical Device Network, a GlobalData ...
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