Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Remember that no prescription is required. Our choice today is caramel apple, for those of you tracking such things. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day and please do stay in touch. Your insights are always welcome. …
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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