Amplia Therapeutics Receives Fast Track Designation from FDA for Advanced Pancreatic Cancer Treatment
Amplia Therapeutics Limited (ASX: ATX), a pioneering biopharmaceutical company, is thrilled to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to its innovative Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.
Key Highlights:
- Fast Track Designation granted to Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer
- Facilitates expedited review and development of investigational drugs
The Fast Track Designation signifies the potential of narmafotinib to outperform existing therapies in treating serious conditions like advanced pancreatic cancer. It expedites the drug’s development process, allowing patients to access it sooner. This designation also enables the company to have closer collaboration with the FDA, potentially leading to Accelerated Approval and Priority Review for narmafotinib. Previously, the FDA had granted Orphan Drug Designation to narmafotinib for pancreatic cancer.
Dr. Chris Burns, the CEO and Managing Director of Amplia Therapeutics, expressed: “The Fast Track Designation for narmafotinib marks a significant milestone for our company. It paves the way for closer collaboration with the FDA to accelerate our clinical program and gather compelling evidence for regulatory approval in this challenging disease.”
Amplia’s clinical trial for advanced pancreatic cancer, the ACCENT trial, is currently ongoing in Australia and South Korea. The company also recently received clearance from the US FDA for an Investigational New Drug (IND) application for a trial of narmafotinib in pancreatic cancer in the United States.
This announcement has been approved for release by Amplia Therapeutics’ Board of Directors. For the complete ASX Release, click here.
Disclaimer: This article contains information sourced from Amplia Therapeutics and is intended for informational purposes only. It is not financial product advice. Readers are advised to conduct their own research and due diligence before making any investment decisions. Refer to our full disclaimer for more information.