FDA Expedites Narmafotinib for Advanced Pancreatic Cancer

The United States Food and Drug Administration (FDA) has awarded Fast Track Designation to Amplia Therapeutics Limited for their lead drug, narmafotinib, aimed at the treatment of advanced pancreatic cancer. This designation is designed to streamline the development and expedite the review process of drugs that show potential for significantly improving treatment options for serious conditions.

Fast Track Designation provides several advantages to drug developers. It allows more frequent meetings and written communication with the FDA, aimed at ensuring the timely collection of necessary data and evidence required for regulatory approval. Additionally, drugs under Fast Track Designation may qualify for Accelerated Approval and Priority Review in the future, further hastening their availability to patients.

Amplia Therapeutics’ CEO and Managing Director, Dr. Chris Burns, highlighted the significance of this achievement. He emphasized that this milestone enables the company to closely collaborate with the FDA, accelerating the clinical program for narmafotinib and gathering robust evidence for its approval. This is particularly important given the devastating impact of pancreatic cancer.

The ACCENT trial, Amplia’s ongoing clinical trial for advanced pancreatic cancer, is currently being conducted in Australia and South Korea. Earlier in the year, the FDA also cleared the company's Investigational New Drug (IND) application for a trial in the United States, which is now in advanced planning stages.

Narmafotinib, also known as AMP945, is Amplia's leading inhibitor of the protein Focal Adhesion Kinase (FAK). This protein is over-expressed in pancreatic and other cancers and is increasingly recognized as a vital target in solid tumor treatments. Narmafotinib has demonstrated promising results in various preclinical cancer studies, showcasing its potency and selectivity as a FAK inhibitor. The drug has completed a healthy volunteer study and is currently undergoing an open-label Phase 2a trial in pancreatic cancer. In this trial, the combination of narmafotinib with chemotherapies gemcitabine and Abraxane® is being evaluated for safety, tolerability, and efficacy.

Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing a pipeline of FAK inhibitors for cancer and fibrosis. FAK is an increasingly important target in cancer treatment, particularly in fibrotic cancers like pancreatic and ovarian cancers. Beyond cancer, FAK also plays a critical role in various chronic diseases, including idiopathic pulmonary fibrosis (IPF).

The Fast Track Designation for narmafotinib marks a pivotal step for Amplia Therapeutics, reinforcing their commitment to advancing innovative treatments for severe and debilitating diseases. With this designation, the company aims to bring hope to patients suffering from advanced pancreatic cancer by making effective treatments available sooner.