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Inside information on cancer research and drug development

Regulatory News

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors

Vote may lead to rollback of some indications held by BMS and Merck

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The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

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Jacquelyn Cobb
Associate Editor
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FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, 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-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
Byline
Jacquelyn Cobb
Associate Editor
Table of Contents

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