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All Oncology News

In a 6 to 2 vote, the FDA’s Oncologic Drugs Advisory Committee voted against maintaining the accelerated approval of pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of therapy.

The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.