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
Amplia’s clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
[1] Investigational New Drug |
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane ® is…
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