RE:RE:Fast Track Designation - the purposeDecember 20, 2022 - Accelerated Approval Reforms in Congress Spending Bill
"When Robert Califf, M.D., retook the helm of the FDA earlier this year, reforming the accelerated approval pathway for new drugs was one of his top priorities.
Fast forward almost a year and those reforms are close to being cemented into law after they slid through negotiations to make the latest draft of Congress’ annual spending bill, which was unveiled Tuesday morning. If passed, the bill would codify more power for the FDA, namely giving the agency the power to request that confirmatory trials are initiated before a company receives accelerated approval. Once a company does receive an accelerated approval, it will be required to provide confirmatory trial status reports to the FDA every six months. "
Accelerated approval allows therapies to be approved based on evidence that they are reasonably likely to predict clinical benefit, rather than more straightforward efficacy data.
[ONCY is pursing the surrogate endpoints of ORR and PFS along with the primary endpoint of OS]
Companies using the pathway are able to make their case using surrogate data rather than evidence of clinical benefit, on the condition that the company confirms clinical benefit in a follow-up confirmatory trial.
https://www.fiercebiotech.com/biotech/accelerated-approval-reforms-are-precipice-becoming-law-cementing-califf-proposals
[ By ONCY initiating a Phase 3 registration study ONCY (or acquirer) will be able to pursue an FDA accelerated approval request that also conforms to the new reforms set out in the Congress spending bill ]