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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, gastric, and hepatocellular cancers. After hearing presentations from FDA staff and the sponsors for the three drugs, the panel will vote whether to recommend for or against continued approval of each indication and whether additional studies should be conducted. Other approved indications for the drugs will not be affected by the ODAC recommendations nor will pending applications for other indicati

Juliaa beaverRichard pazdurCharles bankheadEli lillyOncology centerOncologic drugs advisory committeeDrugs advisory committeeNew england journalMedpage todaySmall cell lung cancerBreast cancerTriple negative breast cancerசார்லஸ் வங்கித் தலைஎலி லில்லிபுற்றுநோயியல் மையம்புதியது இங்கிலாந்து இதழ்