RE:RE:RE:RE:How does Accelerated Approval work 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, like progression free survival (PFS), is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, like overall survival (OS), 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, as the FDA has outlined.
And with two Phase 2 clinical trials completed, in metastatic breast cancer, namely IND-213 and Bracelet-1, and with surrogate endpoints of PFS, ORR and mOS reported in Bracelet-1 of 38.2%, 37.5% and a near doubling in median overall survival, respectively, ONCY is the closest to an Accelerated Approval than any other agent in this category of immunomodulators.
Mature overall survival (OS) from the Bracelet-1 study, which quantifies clinical benefit, is expected at anytime unequivocally supports an Accelerated Approval request.
In expectation of the upcoming Phase 2 Bracelet-1 OS data in mBC ONCY has guided on the discussion with the FDA and advised on a planned adaptive 180-200 patient Phase 2b/ Phase 3/confirmatory clinical trial that can seamlessly tranisition from one Phase to another, as an adaptive clinical trial design provides.
ONCY has also advised that it is is able to conduct on this 180-200 patient study on its own.