BALVERSA™ (erdafitinib) approved for advanced or metastatic urothelial carcinoma

Erdafitinib, an oral pan-FGFR inhibitor discovered thorough collaboration between Newcastle University, Astex Pharmaceuticals and Janssen Pharmaceutica, has received accelerated review and approval for treatment in adults with urothelial carcinoma with susceptible FGFR mutations.

BALVERSA™ (erdafitinib) received a Breakthrough Therapy Designation  from the US Food and Drug Administration in March 2018, and a New Drug Application was announced by Janssen six months later. 

Pioneering work on FGFR inhibitors carried out at the NICR by Professors Julie Irving (pictured), Herbie Newell and Hing Leung, supported by Astex Therapeutics Ltd., supported the later optimisation and development of erdafitinib.

Erdafitinib has been approved for urothelial cancer, particularly of the bladder, typically driven by mutants of the fibroblast growth factor receptor, or FGFR. Erdafitinib will be used to treat advanced and metastatic urothelial cancers with mutant FGFR, and has been shown to have durable responses in patients.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “‘We are delighted with the approval of BALVERSA™ and congratulate our valued colleagues at Janssen for their determination and excellent work in the discovery and development of this new medicine. We also congratulate our academic collaborators at Newcastle University for their contribution to our pioneering early collaboration on FGFR that aided in its discovery. Astex continues to strive to discover new medicines for cancer patients and is very proud that BALVERSA™ is the second of our Pharma-partnered products to have been approved in the last two years.’

Last modified: Wed, 05 Feb 2020 13:12:37 GMT