FDA grants fast track for narmafotinib in pancreatic cancer treatment

The US FDA has granted Fast Track Designation to Amplia Therapeutics for its drug narmafotinib, aimed at treating advanced pancreatic cancer. This designation is significant as it allows for expedited development and review of investigational drugs that may offer advantages over existing therapies. The company can now engage more frequently with the FDA, potentially leading to Accelerated Approval and Priority Review in the future. Narmafotinib is a selective inhibitor of Focal Adhesion Kinase (FAK) and has shown promising results in preclinical studies. The drug has completed a healthy volunteer study and is currently undergoing an open-label Phase 2a trial in combination with gemcitabine and Abraxane® to assess its safety, tolerability, and efficacy in patients with pancreatic cancer. The ongoing ACCENT trial is being conducted in Australia and South Korea. Amplia Therapeutics has previously received Orphan Drug Designation for narmafotinib, highlighting its potential in treating serious conditions. The CEO, Dr. Chris Burns, emphasized that this Fast Track Designation is a crucial milestone for the company, enabling closer collaboration with the FDA to accelerate the clinical program and gather compelling evidence for regulatory approval. FAK is increasingly recognized as an important target in cancer treatment, particularly in fibrotic cancers like pancreatic and ovarian cancer. The designation not only enhances the prospects for narmafotinib but also underscores the company's commitment to addressing the challenges posed by this devastating disease.