Astex Pharmaceuticals welcome priority review of cancer drug in US
Cambridge Science Park-based firm worked with Janssen Pharmaceutica NV on erdafitinib
Cambridge Science Park-based Astex Pharmaceuticals has welcomed a decision by the United States Food and Drug Administration (FDA) to grant a priority review to a cancer drug it helped to discover.
The FDA has granted ‘breakthrough therapy designation’ to erdafitinib, a drug developed by Astex and its pharmaceutical collaborator, Janssen Pharmaceutica NV, for the treatment of metastatic urothelial cancer.
In the US, urothelial cancer, particularly of the bladder, is the sixth most common type of cancer.
The designation means the development and regulatory review of erdafitinib will be expedited. It was granted based on positive data from a phase two clinical trial.
Dr Harren Jhoti, president and CEO of Astex in the UK, said: “This is a great endorsement of our scientific approach and our team. Astex is committed to the fight against cancer and so is delighted that erdafitinib has been granted breakthrough therapy designation by the US FDA.
“Congratulations to our valued collaborators at Janssen for their excellent work in advancing erdafitinib to this exciting stage in its development.”
The drug was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of fibroblast growth factor receptor (FGFR) kinase, including for cancer treatments. Janssen is responsible for the clinical development and commercialisation of products arising from the collaboration.
The discovery arose out of pioneering work on FGFR between Astex and the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, at Newcastle University.