The FDA has granted Fast Track designation to Hemerion Therapeutics for its Pentalafen® / Heliance® combination therapy to improve outcomes in the treatment of glioblastoma. This decision means that clinical development can be accelerated and the product can be brought to the US market more quickly.
Fast track status is granted by the FDA to promising therapies that address serious diseases for which there is no satisfactory therapeutic solution.
Fast Track designation: recognition of the importance of Hemerion’s therapeutic approach
Hemerion’s combination therapy targets glioblastoma (GBM), the most common and aggressive form of brain cancer, which affects approximately 150,000 people worldwide each year. The prognosis for this disease is particularly poor, with more than half of patients dying within 15 months of diagnosis.
Hemerion’s combination therapy represents a real innovation in the current standard of care. Used in the operating theatre immediately after tumour resection, it enables cancer cells to be destroyed deep within the tissue without damaging healthy cells. This could significantly reduce the risk of recurrence and improve patient survival.
A boost for clinical development
The fast-track designation follows orphan drug designation in 2021 and the start of a phase I/II clinical trial in 2024. It allows Hemerion to accelerate its clinical development and work more closely and efficiently with the US Food and Drug Administration.
Specifically, it provides Hemerion with several benefits:
- More frequent interactions with the FDA to optimize clinical trial design.
- Eligibility for the FDA’s fast-track procedures (Accelerated Approval, Priority Review and Rolling Review).
This greater flexibility in working with the FDA means shorter validation times, which could save several months in the US approval process.