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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, the agency announced Friday. “While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the […]

MedPage Today

New York

United States

Novel Targeted Drug Approved for Stomach Cancers

The US Food and Drug Administration (FDA) has approved zolbetuximab (Vyloy, Astellas Pharma) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2 positive.  FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. […]

Medscape

FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer

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Gilead Sciences’ Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021. The post Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure appeared first on MedCity News.

MedCity News

Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure

Samuel J. Klempner, MD, discusses the FDA approval of zolbetuximab for CLDN18.2+, HER2–, locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma.

onclive.com

Dr Klempner on the FDA Approval of Zolbetuximab for CLDN18.2+, HER2– Gastric or GEJ Adenocarcinoma

The FDA on Friday approved Astellas’ treatment for a type of gastric cancer, marketed as Vyloy (zolbetuximab). The approval came three weeks ahead of its scheduled PDUFA date of Nov. 9. Vyloy targets a protein called Claudin18.2 that is expressed on the surface of some gastric cancer cells. The drug is now approved in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric o…

Endpoints News

FDA approves Astellas' gastric cancer drug Vyloy ahead of schedule

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option.  CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment to improve …

The AI Journal

Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

This approval marks the first CLDN 18.2-targeted therapy in this patient population.

targetedonc.com

Zolbetuximab Scores FDA Approval in CLDN 18.2+ Gastric/GEJ Cancer

The FDA has approved Vyloy for patients with HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with CLDN18.2-positive tumors.

Novel Targeted Drug Approved for Stomach Cancers

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