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FDA Panel Backs Atezolizumab for mTNBC -- at Least for Now

FDA Panel Backs Atezolizumab for mTNBC -- at Least for Now
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United States , Baylor College Of Medicine , Juliaa Beaver , Richard Pazdur , Matthew Ellis , Stan Lipkowitz , Cancer Research , Oncologic Drugs Advisory Committee , National Cancer Institute , Drug Administration , Women Malignancies Branch , Drugs Advisory Committee , Accelerated Approvals Withdrawn , New England Journal , Malignancies Branch , Baylor College , ஒன்றுபட்டது மாநிலங்களில் , பேலர் கல்லூரி ஆஃப் மருந்து , மேத்யூ நீள்வட்டம் , புற்றுநோய் ஆராய்ச்சி , தேசிய புற்றுநோய் நிறுவனம் , புதியது இங்கிலாந்து இதழ் , பேலர் கல்லூரி ,

FDA Panel to Consider 'Dangling' Oncology Approvals

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 ot ....

Juliaa Beaver , Richard Pazdur , Charles Bankhead , Eli Lilly , Oncology Center , Oncologic Drugs Advisory Committee , Drugs Advisory Committee , New England Journal , Medpage Today , Small Cell Lung Cancer , Breast Cancer , Triple Negative Breast Cancer , சார்லஸ் வங்கித் தலை , எலி லில்லி , புற்றுநோயியல் மையம் , புதியது இங்கிலாந்து இதழ் , சிறிய செல் நுரையீரல் புற்றுநோய் , மார்பக புற்றுநோய் , மூன்று எதிர்மறை மார்பக புற்றுநோய் ,