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' 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'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' 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.
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.
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
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. The therapy, branded as Vyloy, was approved to be used in combination with a type of chemotherapy for patients with a type of cancer which begins in the gastroesophageal junction,
Medpage Today on MSN1d
Novel Targeted Drug Approved for Stomach Cancers
The FDA approved zolbetuximab (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, in combination with ...
Medscape19h
FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer
FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...
Morningstar3d
Triumvira Immunologics Announces Publication Demonstrating the Safety and Efficacy of TAC T Cells Targeting Claudin 18.2 in Solid Tumors
The article, authored by a team of scientists led by Dr. Andreas Bader, Triumvira's Consulting Chief Scientific Officer, details the preclinical pharmacology and safety of TAC01-CLDN18.2 ...
GlobalData on MSN7d
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 ...
Pharmabiz8d
Roche’s IHC companion diagnostic test, VENTANA CLDN18 (43-14A) RxDx Assay to identify patients with gastric or GEJ cancer gets CE Mark approval
RxDx Assay to identify patients with gastric or GEJ cancer gets CE Mark approval: Basel Friday, October 11, 2024, ...