Acute Myeloid Leukemia Coverage From Every Angle
Advertisement
Advertisement

FDA Brief: Eprenetapopt Given Fast Track Designation for TP53-Mutant AML

By: Jocelyn Solis-Moreira, MS
Posted: Tuesday, December 8, 2020

On November 30, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to eprenetapopt for patients with TP53-mutant acute myeloid leukemia (AML). The FDA previously granted Breakthrough Therapy, orphan drug, and Fast Track designations for eprenetapopt for the treatment of patients with TP53-mutant myelodysplastic syndromes (MDS) along with orphan drug designation from the European Medicines Agency for MDS, AML, and ovarian cancer.

Eprenetapopt (also known as APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function, which induces programmed cell death in human cancer cells. Synergy has previously been reported with chemotherapy and immune-oncology checkpoint inhibitors.

In addition to preclinical testing, a phase I/II clinical trial with eprenetapopt has been completed. Early results have shown a favorable safety profile as well as biologic and confirmed clinical responses in hematologic malignancies and solid tumors with mutations in the TP53 gene.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.