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BioWorld - Sunday, May 22, 2022
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Home » Are cancer blockbusters living up to promises? ODAC to weigh in
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Are cancer blockbusters living up to promises? ODAC to weigh in

April 26, 2021
By Mari Serebrov
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As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
BioWorld Regulatory Cancer U.S. FDA

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