Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia’s Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.
HIGHLIGHTS
- The US FDA has granted Fast Track Designation to Amplia’s lead drug narmafotinib in advanced pancreatic cancer
- Fast Track Designation facilitates the development of investigational drugs and allows for expedited review
Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions. It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer.
The Company’s CEO and Managing Director, 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.”
Amplia’s clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea. Earlier this year, the Company announced that the US FDA had cleared its IND1 application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
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Read More: FDA Fast Track Designation for Narmafotinib in Advanced Pancreatic Cancer