Revefenacin has not received FDA approval [1]. The drug, developed by Athenex, is intended for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received treatment with an approved androgen receptor signaling inhibitor and a taxane-based chemotherapy [1].
What is the status of Revefenacin's clinical trials?
The United States Food and Drug Administration (FDA) has not approved revefenacin. Athenex announced in January 2023 that they had submitted a New Drug Application (NDA) for revefenacin to the FDA for the treatment of mCRPC [1]. The application was based on data from the Phase 3 ROTOR trial [1].
When might Revefenacin be approved?
The FDA's review timeline for NDAs typically involves a decision within 10 months of submission [2]. However, the FDA may request additional information or convene advisory committees, which can extend this period. As of now, there has been no announcement regarding an FDA decision on revefenacin's approval [1].
What is Revefenacin and how does it work?
Revefenacin is an orally administered topical formulation of the selective androgen receptor (AR) signaling inhibitor [1]. It is designed to target AR signaling pathways that drive prostate cancer growth [1].
What prostate cancer treatments are already approved by the FDA?
A number of treatments are currently approved by the FDA for metastatic castration-resistant prostate cancer (mCRPC), including androgen receptor signaling inhibitors such as abiraterone acetate, enzalutamide, and apalutamide, as well as taxane-based chemotherapies like docetaxel and cabazitaxel [3]. Revefenacin aims to treat patients who have progressed on these existing therapies.
What is the significance of an FDA approval for Revefenacin?
FDA approval would make revefenacin available to patients with mCRPC who have exhausted other treatment options. This could provide a new therapeutic avenue for a difficult-to-treat cancer stage [1].
Sources:
[1] https://www.drugpatentwatch.com/p/revefenacin
[2] https://www.fda.gov/patients/drug-development-process/step-8-drug-review-process
[3] https://www.cancer.gov/types/prostate/treatment/mcrpc-treatment-pdq