RE:RE:RE:RE:RE:ONCY announces Pelareorep ≥50% ORR & mPFS Improvements " The ASCO Phase 2 Bracelet-1 clinical study presentation to May 2023 revealed that pelareorep as a single agent (Cohort 2 - pela+pax) demonstrated a very strong PFS reading of 86% which sets pelareorep up for a accelerated approval with the near full enrollment of a Phase 3 registration study.
"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
[The results of ONCY's Bracelet-1 Phase 2 study provided clear empirical evidence that pelareorep as a single agent surpassed the surrogate endpoints of ORR and PFS over the historical SOC control arm of paclitaxel alone, along with meeting the study's primary objective of surpassing ORR over control, thus meeting the FDA's requirements for an accelerated approval for pelareorep as a single agent.]
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit." [ As would happen with the filing of pelareorep's Phase 3 study. ]
https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program