The FDA appears to be tightening expedited approval requirements: confirmation testing is required at the time of filing

The U.
S.
FDA seems to have quietly begun reforming
accelerated approval programs.

ADC Therapeutics said Nov.
8 in its third-quarter earnings report, "At the FDA After providing strong guidance to reconsider the accelerated approval pathway, the company is going back in time to re-evaluate its experimental novel antibody conjugate (ADC) Cami (camidanlumab) targeting CD25 tesirine）
。 The FDA's guidance is that randomized confirmatory Phase 3 studies must proceed smoothly and preferably be fully enrolled
at the time of submission of the BLA application.
”

If what the ADC says is true and applies to other businesses seeking expedited approval, the FDA This guidance could make progress on accelerating enrollment in confirmatory trials, many of which in the past could have lasted for years, but it could also drive smaller companies away from the accelerated approval track, as these companies may not have the funds to conduct confirmatory trials
before receiving the benefits of accelerated approvals.

Regener's CEO, Len Schleifer, also echoed ADC's claims, noting in a recent earnings call that "regulators have recently focused on carrying out 3 at the time of filing Phase trial and complete a large number of enrollments before they will grant accelerated approval
.
”

FDA Oncology Center of Excellence officials have previously made clear the need to ensure that companies are conducting confirmatory trials when granting accelerated approval, as the data shows the median time to revocation if confirmatory trials are already underway at the time of approval 3.
8 years, compared to a median time of revocation of 7.
3 years
if no confirmatory trials had been conducted at the time of approval.

FDA Commissioner Robert Califf has already spoken publicly about the need to reform the accelerated approval process and has said he wants to conduct confirmatory studies sooner, preferably at the time of submission
.
But ADC What appears to be the FDA's first time putting this idea into practice
.

Because of the FDA's current new policy on accelerated approval applications, ADC companies said they may submit a BLA for Cami next year Apply, as the company says it will take at least two years to be fully enrolled
.
While the company says it is working with the FDA to promote Cami Moving forward, but the company has also "suspended any substantial investment in the Hodgkin lymphoma project" and will evaluate its options
.

Rachel Sachs, a law professor at the University of Washington School of Law, said, "I think in general, the FDA More power can be exerted than before to control the terms of
the accelerated approval program.
This is a very obvious example
.
I can understand why the FDA There would be a preference for clearer statutory authority to do this, but some argue that the current terms of the program already allow the FDA to do so
.
”