🎯 The designation aims to expedite the review and approval process for drugs that treat serious conditions.
🧪 NOX-A12 is a CXCL12 inhibitor that will be used in combination with radiotherapy and bevacizumab.
📅 Recent clearance of TME Pharma’s Investigational New Drug application was a prerequisite for the FDA’s Fast Track designation.
👨⚕️ The company hopes that the Fast Track designation will attract industrial and financial partners.
Introduction:
TME Pharma, a company developing novel therapies for cancer treatment, has received Fast Track designation from the US Food and Drug Administration (FDA) for its CXCL12 inhibitor, NOX-A12, in combination with radiotherapy and bevacizumab for the treatment of glioblastoma. Glioblastoma is an aggressive form of adult brain cancer that is resistant to chemotherapy. This designation is intended to expedite the development and review process of the therapy and address the unmet medical needs of glioblastoma patients.
- TME Pharma’s CXCL12 inhibitor, NOX-A12, has received Fast Track designation from the FDA for the treatment of glioblastoma.
- The designation is for NOX-A12 in combination with radiotherapy and bevacizumab in the newly diagnosed setting where the tumor is resistant to chemotherapy and measurable tumor remains after surgery.
- Fast Track designation allows for more frequent interactions with the FDA during the clinical development process and the potential for accelerated approval and priority review.
- TME Pharma recently received clearance from the FDA for a Phase 2 study of NOX-A12 in glioblastoma.
- The company’s GLORIA Phase 1/2 study showed promising survival data for NOX-A12 in chemotherapy-resistant patients with residual tumor after surgery.
Conclusion:
TME Pharma’s CXCL12 inhibitor, NOX-A12, has been granted Fast Track designation by the FDA for the treatment of glioblastoma. This designation will expedite the development and review process of the therapy, which shows promise in addressing the unmet medical needs of glioblastoma patients. TME Pharma’s recent clearance for a Phase 2 study and positive survival data from their GLORIA study further support the potential of NOX-A12 in glioblastoma treatment.
