PRESS RELEASE


BALVERSA™ gains US marketing approval following early discovery work funded by CRUK

2019-05-29 00:00:00

The fibroblast growth factor receptor (FGFR) kinase inhibitor BALVERSA™ (erdafitinib) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy, following Breakthrough Therapy Designation. BALVERSA™ is the first FGFR kinase inhibitor to receive US FDA approval.

BALVERSA™ was discovered by Astex and Janssen Pharmaceutica N.V. (Janssen) as part of a 2008 collaboration and licence agreement to identify novel, small molecule inhibitors of FGFR kinase, including for the treatment of cancer.

Prior to the collaboration with Janssen, the Cancer Research UK Drug Discovery Group at the Northern Institute for Cancer Research, Newcastle University performed pioneering work on FGFR with Astex under joint-funding from Cancer Research UK, underlining the quality of UK science and strengths in academic-biotech collaboration, and laying the foundations for this discovery.

Emeritus Professor Herbie Newell, the academic lead on the original Newcastle-Astex collaboration, said “The success of BALVERSA™ is another excellent example of the importance of academic drug discovery and academia-industry collaboration. Newcastle identified FGFR as a target and in collaboration with Astex applied cutting-edge technology to develop tool compounds that generated critical proof-of-concept data. The subsequent Astex/Jansen collaboration has generated an important new cancer treatment, adding to the increasing number of targeted therapies for precision medicine.”

Tony Hickson, Cancer Research UK’s chief business officer, said, “We are delighted with the approval of BALVERSA™ and congratulate our colleagues at Astex and their collaborators at Janssen. It is wonderful to see how the pioneering early collaboration on FGFR at Newcastle has been taken forward and aided in the discovery of a drug that could be of real value to patients.”

Notes to editors