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FDA, VYLOY and Astellas
FDA Approves First-in-Class Drug for Gastric Cancer
Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.
VYLOY: Astellas’ gastric cancer therapy approved in US
Astellas Pharma today announced that the US Food and Drug Administration (FDA) has approved VYLOY (zolbetuximab-clzb) in combination with
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.
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,
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 identify claudin 18.2–positive tumors and thus patients who may be eligible to receive zolbetuximab.
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
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 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' 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 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. The pharmaceutical company said Friday the FDA approved the drug for use in combination with fluoropyrimidine-and-platinum-containing chemotherapy.
GlobalData on MSN
8d
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 ...
PMLiVE
24d
Astellas’ Vyloy combination approved by EC as first-line gastric cancer treatment
Vyloy
(
zolbetuximab
) has been authorised for use alongside fluoropyrimidine- and platinum-containing chemotherapy to treat adults with locally advanced unresectable or metastatic human epidermal ...
Pharmabiz
8d
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, ...
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