Clinical Pipeline

DiscoveryPhase 1Phase 2Phase 3Marketed

Balversa® (erdafitinib)

FGFr inhibitor (Oncology)


Partner: logo_janssen

Mechanism of Action: Fibroblast growth factor receptor (FGFr) inhibition

Indication: Oncology

Discovery: Investigational compound Balversa™  (erdafitinib, formerly known as JNJ42756493), was discovered in collaboration with Janssen Pharmaceutica, N.V. as part of a partnership which commenced in June 2008. Astex’s FGFr inhibitor program originated from a collaboration initiated in 2005 with the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre (Newcastle University UK), and Cancer Research Technology Limited.

How this therapy can help

Activating mutations, amplifications and over-expression of FGFs have been implicated in the pathogenesis of a variety of human tumors including breast, prostate, colon and bladder cancers. Inhibition of FGFrs is expected to restore control of proliferative processes driven by these aberrations.

Marketed product

Balversa™ received US marketing approval by the FDA in April 2019 for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC), which has susceptible fibroblast growth factor receptor FGFR3 or FGFR2 genetic alterations. This is the first FGFR inhibitor to be approved by FDA. For full prescribing and safety information please see here.

A companion diagnostic has also been approved allowing for rapid identification of patients with the fibroblast growth factor receptor FGFR3 or FGFR2 genetic alterations.

Clinical status

Balversa™ is also being evaluated in Phase 2 clinical trials in patients with prostate cancer, advanced hepatocellular carcinoma, advanced refractory solid tumours, childhood non-hodgkin lymphoma, multiple myeloma, advanced non-small lung cancer, esophageal cancer or cholangiocarcinoma.