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A pair of PD-1 immunotherapies used in advanced hepatocellular carcinoma (HCC) met sharply different receptions from FDA advisers reviewing accelerated approvals that failed to show benefit in confirmatory trials.
In considering the two agents for previously treated HCC, the Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously recommended that FDA maintain its accelerated approval of pembrolizumab (Keytruda), by a vote of 8-0, but split over nivolumab (Opdivo), with a 5-4 vote in favor of revoking the indication.
The divided decision largely stemmed from whether ongoing trials would offer new evidence to support the indications. ODAC members took a wait-and-see approach with pembrolizumab given the imminent readout of KEYNOTE-394, a placebo-controlled second-line trial being conducted in Asia. But with nivolumab, they remained unconvinced that any ongoing trial from drugmaker Bristol Myers Squibb (BMS) would adequately provide insig ....

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