Amplia is pleased to announce that it has that the United States Food and Drug Administration (FDA) has granted Fast Track Designation the Company’s Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.
Fast Track Designation facilitates the development of investigational drugs and allows for expedited review. It is available to drugs that provide an advantage over current therapies that treat serious conditions and is designed to get these drugs to patients earlier. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA.
Amplia CEO and MD, Dr Chris Burns, commented:
“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.”
Click to read the ASX release.