Stricter policy on Accelerated Approvals comes into effect

9 November 2022

Hopes that the novel antibody-drug conjugate (ADC) camidanlumab tesirine (Cami) might soon secure a review under the Accelerated Approval scheme have been dashed.

Swiss biotech ADC Therapeutics (NYSE: ADCT) revealed that the US Food and Drug Administration had provided “strong guidance” that its confirmatory study must be “well underway,” for that to happen.

That is in line with signals given by the FDA, with Commissioner Robert Califf having indicated that the system is in line for some changes.

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