The FDA narrowed the indications for pembrolizumab (Keytruda) and nivolumab (Opdivo) in gastric, gastroesophageal junction (GEJ), and esophageal cancers, according to letters sent to the respective drugmakers.

The agency had originally granted PD-L1 agnostic approval for the two immune checkpoint inhibitors as first-line treatment for advanced gastroesophageal cancers.

However, based on phase III trial data that became available since those initial approvals, the FDA's Oncologic Drugs Advisory Committee last year voted that PD-1 inhibitors do not have a favorable risk/benefit profile in gastric/gastroesophageal junction (GEJ), and esophageal cancers with PD-L1 expression <1.

Now, nivolumab -- in combination with chemotherapy -- is indicated for the first-line treatment of adults w

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