Ameet Mallik, ADC Therapeutics CEO

Start­ing with ADC, FDA calls for ful­ly en­rolled con­fir­ma­to­ry tri­al pri­or to ac­cel­er­at­ed ap­proval sub­mis­sion

When Con­gress punt­ed on adding new ac­cel­er­at­ed ap­proval re­forms to the user fee leg­is­la­tion, many won­dered how and when the agency would get around to fix­ing the is­sue of en­sur­ing these con­fir­ma­to­ry tri­als are com­plet­ed in a more time­ly man­ner.

Now, FDA ap­pears to be tak­ing the mat­ter in­to its own hands.

ADC Ther­a­peu­tics said on Tues­day, as part of its Q3 earn­ings re­port, that it’s tak­ing a step back to reeval­u­ate its ex­per­i­men­tal CD25-tar­get­ed ADC Ca­mi (cami­dan­lum­ab tesirine) af­ter the FDA “pro­vid­ed strong guid­ance that, for it to con­sid­er an ac­cel­er­at­ed ap­proval path, a ran­dom­ized con­fir­ma­to­ry Phase 3 study must be well un­der­way and ide­al­ly ful­ly en­rolled at the time of any BLA fil­ing.”

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.