Breakthrough Therapy Designation4 Nov 2024 19:54
Breakthrough Therapy Designation – The FDA uses this designation to speed the development and review of the drugs that are intended to treat a serious condition. In these cases, researchers have preliminary data that indicates the drug is likely to be a substantial improvement over current treatment.
Breakthrough Therapy Designation
The Advancing Breakthrough Therapies for Patients Act was enacted in 2012 to expedite the development of drugs intended to treat a serious or life-threatening disease, with preliminary clinical evidence suggesting substantial improvement over existing therapies. In the manuscript entitled “Developing Standards for Breakthrough Therapy Designation in Oncology,” the authors propose criteria for the Breakthrough designation and pathways for the development of drugs where “unprecedented efficacy” signals are observed in early clinical trials.(3) The authors propose:
* In the case of no standard of care, a Phase Ib expansion cohort or single arm pivotal trial could lead to full or accelerated approval.
* Where early data suggests substantial improvement in efficacy compared to standard of care, a randomized phase II trial could support full approval.
https://pmc.ncbi.nlm.nih.gov/articles/PMC4167364/
Standard of care for STS is doxorubicin.
Standard of care for TNBC treatment and uses drugs such as anthracyclines (e.g., doxorubicin) and taxanes (e.g., paclitaxel)
AVA6000 replaces Dox as standard of care.
So there is a chance Phase Ib expansion cohort or single arm pivotal trial could lead to full or accelerated approval.
Sign In
Follow the stocks
