RE:FDA's Head of CBER wants faster approvals with SE/biomarkersONCY has plenty of cash on hand, $47 million to be exact, to initiate a Phase 3 mBC trial and apply for Accelerated Approval on the current number of patients that underwent the two ER+/Her2- Phase 2 mBC clinical and on the surrogate endpoints (ORR and PFS) that have been already reported. With ONCY registering another 10-20 more patients in a Phase 3 ONCY will trigger the US$85 million payment from Adlai Nortye. Since ONCY is already undergoing iterative meetings with the FDA and with a biomarker/surrogate endpoints Phase 3 mBC sufficiently underway, ONCY can successfully apply to the FDA for an Accelerated Approval for pelareorep in mBC. The Phase 3 pancreatic cancer is already on the road towards AA through PanCan's programming.
Read this and stop askig stu/I'id question.
July 28, 2023 - The FDA doesn’t “have to get to 100% certainty between an accelerated approval endpoint and a clinical endpoint," according to Peter Marks, MD, PhD and head of the FDA's Center for Biological Evauation and Researh.
One of the ways that new treatment options can happen for rare diseases and orphan drugs is through accelerated approvals, a regulatory pathway whereby drug developers get earlier approval based on data that's likely to predict clinical benefit for serious conditions. Those data points, called surrogate endpoints or biomarkers, differ depending on the disease, but are easier to accrue than clinical endpoints.
The agency can mitigate uncertainty by “using science to the fullest extent," according to Marks—be it available animal data or strong human biomarkers related to, for example, the expression of a particular protein