Keytruda, Opdivo’s Retention Of Hepatocellular Carcinoma Indication May Depend On Ongoing Studies
US FDA advisory committee to consider whether new studies can take place of failed confirmatory trials to support accelerated approvals. The agency also wants the panel to consider the changing landscape of HCC following the approval of atezolizumab in combination with bevacizumab.
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In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.
Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.
Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.