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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.

William J. Gradishar, MD

As longer-term follow-up data become available for several agents approved for HER2-positive metastatic breast cancer, investigators are looking closely at the characteristics of patients enrolled in those clinical trials to determine appropriate treatment strategies in the third-line setting and beyond.