In the three years since the US Food and Drug Administration granted the first PD-1 inhibitor indications for first-line use in esophageal and gastric cancers, the agency has amassed enough data on the impact of PD-L1 expression to ask its Oncologic Drugs Advisory Committee to revisit the all-comers labeling for Merck & Co., Inc.’s Keytruda (pembrolizumab), Bristol Myers Squibb Company’s Opdivo (nivolumab) and BeiGene, Ltd.’s Tevimbra (tislelizumab-jsgr).
US FDA Revisits PD-L1 Biomarker In Gastric, Esophageal Cancers
The Oncologic Drugs Advisory Committee will discuss restrictions for patients expressing PD-L1 in first-line labeling for Merck’s Keytruda, Bristol Myers Squibb’s Opdivo, and a pending NDA for BeiGene’s Tevimbra.
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