The panel’s vote follows data showing patients with unresectable or metastatic esophageal squamous cell carcinoma and HER2-negative, microsatellite stable gastric/gastroesophageal adenocarcinoma who have a PD-L1 expression of less than 1% experience the risks of immunotherapy without the benefits.
Requiring a PD-L1 of 1% or higher for the immunotherapies would align FDA guidance with guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network.
The requirement would also apply to the immune checkpoint inhibitor tislelizumab, according to the Medscape report.
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