FDA Grants Fast Track Designation for Fibroid-Targeting Inhibitor

The US Food and Drug Administration (FDA) granted Fast Track Designation to Amplia Therapeutics Limited’s narmafotinib for advanced pancreatic cancer on September 19.

The phase 2a ACCENT clinical trial investigating safety, tolerability, and efficacy of narmafotinib is ongoing in Australia and South Korea. Earlier this year, Amplia announced that the FDA cleared its Investigational New Drug Application for a US-based trial, which is in advanced planning stages.

Narmafotinib is a focal adhesion kinase (FAK) inhibitor that may help patients have a better response to standard-of-care chemotherapies, gemcitabine, and nab-paclitaxel. The FAK inhibitor is highly potent in solid tumors (eg, pancreatic, ovarian) and fibrosis (eg, idiopathic pulmonary fibrosis).

The drug’s mechanism of action aims to break down the fibrotic tissue shield to allow for more effective chemotherapy treatment.

Amplia CEO Dr. Chris Burns noted that “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.”