J&J Announces CHMP Endorsement for Balversa in Bladder Cancer

Johnson & Johnson (J&J) has announced that the European Medicines Agency’s human medicines committee has recommended the approval of Balversa (erdafitinib) for treating a specific type of bladder cancer. The Committee for Medicinal Products for Human Use (CHMP) has suggested using this once-daily oral medication for adult patients with unresectable or metastatic urothelial carcinoma (UC). These patients must have susceptible FGFR3 genetic alterations and should have previously undergone at least one line of therapy containing either a PD-1 or PD-L1 inhibitor in the advanced treatment setting.

Urothelial carcinoma (UC) represents about 90% of all bladder cancer cases, and up to 20% of individuals with metastatic UC exhibit FGFR genetic alterations. Balversa is now recognized as the first targeted treatment to receive a positive recommendation from the CHMP for this patient group. The committee's decision was informed by favorable data from the first cohort of the phase 3 THOR study. This study has been assessing the efficacy and safety of Balversa compared to chemotherapy in patients with metastatic or unresectable UC and specific FGFR alterations who had been previously treated with an anti-PD-L1 agent.

The study achieved its primary goal of overall survival, with Balversa showing a 36% reduction in the risk of death compared to chemotherapy in the patient group. Henar Hevia, the senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, commented that the CHMP's recommendation signifies important progress in improving outcomes for patients diagnosed with bladder cancer featuring FGFR alterations. He noted that pending final approval, J&J looks forward to offering this new treatment option to eligible patients across the region as soon as possible.

Earlier this year, the US Food and Drug Administration approved the FGFR tyrosine kinase inhibitor to treat adults with locally advanced or metastatic UC with susceptible FGFR3 genetic alterations, whose disease has progressed after at least one previous systemic therapy. Besides its current indications, Balversa is also being investigated as a once-daily oral tablet for several other conditions. These include high-risk non-muscle-invasive bladder cancer, locally advanced or metastatic UC with FGFR3 or FGFR2 gene alterations, advanced solid tumors driven by FGFR1 to 4 alterations, and both non-muscle-invasive and muscle-invasive bladder cancer with specific FGFR alterations.