Johnson & Johnson's Balversa becomes first targeted therapy for metastatic bladder cancer in US

Johnson & Johnson said Friday that it received accelerated approval by the FDA regarding its marketing application for Balversa (erdafitinib) to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) carrying certain FGFR genetic alterations. "We're in an era of more personalised or precision medicine," remarked Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, adding "today's approval represents the first personalised treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer."

The filing was supported by data from the Phase II BLC2001 study of 87 patients with locally advanced or metastatic bladder cancer, carrying FGFR3 or FGFR2 genetic alterations, that progressed following chemotherapy. Results unveiled in June 2018 showed that the once-daily, oral pan-FGFR tyrosine kinase inhibitor was associated with an objective response rate of 32.2 percent, as well as a median duration of response of 5.4 months. About a quarter of the participants had been treated with anti PD-L1/PD-1 therapy before, with Johnson & Johnson noting that responders included patients who had previously not seen any benefit on such therapy.

The FDA on Friday also approved QIAGEN's therascreen FGFR RGQ RT-PCR kit as a companion diagnostic for use with Balversa.

Johnson & Johnson and Astex Pharmaceuticals jointly developed Balversa under the terms of a 2008 agreement. The drug was previously awarded a breakthrough therapy designation by the FDA for the treatment of mUC.

The agency approval comes after Johnson & Johnson inked a deal with Immunomedics earlier this month covering the promotion of Balversa in the US. 

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