STAT+: Pharmalittle: ADC backs off accelerated approval after FDA demands confirmatory trial; explaining the Supreme Court’s split on drug-patent cases

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ADC Therapeutics will not seek accelerated approval of its Hodgkin lymphoma drug based on Phase 2 results, because the U.S. Food and Drug Administration will not review it unless a confirmatory trial is already “well underway and fully enrolled,” Pharmaphorum tells us. The company said that enrolling such a study would take up to two years, and its plan to file for approval of the drug next year is on hold while it is in dialogue with the FDA about a path forward for the program. For now, ADC is halting all investment in the drug. The decision to require a Phase 3 program to be in play before an accelerated approval — if it becomes general policy — would point to a much tougher agency stance.

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