FDA Grants Fast Track Designation to HiberCell's HC-7366 for Acute Myeloid Leukemia Treatment
HiberCell, Inc., a clinical-stage biotechnology company focused on developing therapeutics to combat advanced cancer and cancer resistance, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HC-7366 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia. The FDA’s Fast Track program aims to facilitate the development and expedite the review of novel therapies designed to treat serious conditions and address significant unmet medical needs. Publish Date: 23-10-2024 Source: HiberCell, Inc. Acute myeloid leukemia (AML) is characterized by the uncontrolled growth of undifferentiated myeloid stem cells, accumulating immature myeloblasts. The standard approach to induce remission in AML has been a chemotherapy regimen combining cytarabine and anthracycline (commonly called “7+3”) for thirty years. However, relapse and refractory disease persist despite its long-standing use, with a median over...