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 overall survival of under 6 months. Several factors have been linked to worse outcomes, including age exceeding 65 years, unfavorable cytogenetics, and a first complete remission lasting less than 12 months. The treatment of relapsed or refractory AML presents low remission rates following initial salvage therapy, and these rates decline further with subsequent treatment attempts. The sole curative option for relapsed or refractory AML patients is a hematopoietic stem cell transplant, but its high mortality risk renders it unsuitable for many patients.

However, the current Relapsed or Refractory Acute Myeloid Leukemia (AML) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Selinexor, Tuspetinib, ASP2215, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Relapsed or Refractory Acute Myeloid Leukemia (AML) treatment. The key companies in the advanced development stage are Antengene Corporation, Aptose Biosciences Inc., Astellas Pharma Inc, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Relapsed or Refractory Acute Myeloid Leukemia (AML) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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