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.”
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