Amplia Therapeutics' FDA Fast Track Designation for Narmafotinib

Amplia Therapeutics Limited (ASX:ATX) has received Fast Track Designation from the United States Food and Drug Administration (FDA) for its lead drug narmafotinib in the treatment of advanced pancreatic cancer. This designation aims to expedite the development of investigational drugs, allowing for accelerated review processes and closer collaboration with the FDA.

Amplia Therapeutics CEO and Managing Director, Dr Chris Burns, on Fast Track Designation

Fast Track Designation for narmafotinib is a significant milestone for the Company. With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease.

Amplia Therapeutics' Outlook and Ambitions

Amplia Therapeutics' narmafotinib has been granted Fast Track Designation by the FDA, signifying a crucial step in expediting the drug's development for advanced pancreatic cancer treatment. This designation provides the Company with enhanced opportunities for collaboration and communication with the FDA, potentially leading to Accelerated Approval and Priority Review in the future. The Company's CEO, Dr Chris Burns, emphasized the significance of this milestone, highlighting the potential to accelerate the clinical program and gather compelling evidence for regulatory approval. Amplia's clinical trial for narmafotinib in advanced pancreatic cancer, the ACCENT trial, is currently ongoing in Australia and South Korea, with plans for a trial in the US in advanced planning stages. Narmafotinib, a potent and selective inhibitor of FAK, has shown promising data in preclinical cancer studies and is currently in an open-label Phase 2a trial in pancreatic cancer. Amplia Therapeutics aims to leverage the Fast Track Designation to advance the development of narmafotinib, potentially offering a new treatment option for patients battling advanced pancreatic cancer.