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Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging.
Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging.
Last year, the FDA approved almost a dozen novel cancer drugs and expanded indications for many more, while growing agency scrutiny led to numerous withdrawals.
Immunotherapy with checkpoint inhibitors has been a game changer for some cancer types, but development of this drug class has been uncoordinated and problematic, say FDA officials.
email article The FDA will conduct an unprecedented public review of accelerated approval for oncology-drug indications left "dangling" for lack of confirmatory evidence to support benefits observed in earlier studies. Beginning at 1 p.m. ET on Tuesday and continuing through Thursday, the FDA Oncologic Drugs Advisory Committee (ODAC) will hear evidence supporting a total of six indications for three different immune checkpoint inhibitors: nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). The three-day review pertains to indications in breast, urothelial, gastri...