FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo
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.
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Keeping Track: GSK Earns New Claims For Shingrix, Nucala; Keytruda’s TNBC Label Grows; CRL For Iterum
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency
US FDA Oncology Center of Excellence Director Rick Pazdur says PD-1/L1 drugs are very similar and hypothesizes that when competitors show differing results in the same indication it's more about trial design than the drug. FDA oncology experts also weighed in on regulatory clearance of Chinese-developed checkpoint inhibitors and trial endpoints that have come under outside scrutiny.
The three-day advisory committee was intended to ‘put companies on notice’ about the importance of confirmatory trials. The result? Mission accomplished.