Breakthrough therapy status for erdafitinib in bladder cancer

15 March 2018

The US Food and Drug Administration has granted Breakthrough Therapy designation for erdafitinib in the treatment of urothelial cancer.

The drug is being developed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) group of Janssen companies. Last year J&J included erdafitinib (JNJ42756493) in a list of late-stage blockbuster products projected to be filed for regulatory approvals between 2017 and 2021.

Erdafitinib was discovered by UK-based Astex Pharmaceuticals 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 the treatment of cancer. Janssen is responsible for the clinical development and commercialization of all products arising from this collaboration. In October 2013 Astex became a wholly-owned subsidiary of Japan’s Otsuka Pharmaceutical (TYO: 4578), under an around $900 million takeover deal.

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