ARTICLE | Regulation

ADC move signals FDA ready to fix confirmatory trial process 

Biotech says agency wants confirmatory trial under way for cami at time of BLA

November 9, 2022 1:42 AM UTC

FDA’s oncology center has made good on its promise to start requiring companies to have confirmatory trials under way at the time of accelerated approval, causing ADC Therapeutics to delay submission of a BLA for camidanlumab tesirine.

ADC Therapeutics S.A. (NYSE:ADCT) said Tuesday in its 3Q22 financial results update that the company will not submit a BLA next year for “cami” in Hodgkin lymphoma; it has also paused material investments in the program following “strong guidance” from FDA that a randomized confirmatory Phase III trial “must be well underway and ideally fully enrolled” at the time of filing for the agency to consider the therapy under accelerated approval. ADC Therapeutics estimates fully enrolling such a trial would take two years. ...

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ADC Therapeutics S.A.