Balversa is now indicated in the US for the treatment of adult patients having locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration called FGFR3 or FGFR2, and whose condition had progressed during or after being previously treated with platinum-containing chemotherapy.
According to Janssen, continued approval for its drug for the indication may be based on verification and description of clinical benefit in confirmatory trials.
The FDA said that patients should be selected for treatment with the Janssen drug using a companion diagnostic device approved by it.
Janssen Research & Development oncology global therapeutic area head Peter Lebowitz said: “We recognize the significant unmet need that persists in the treaent of men and women diagnosed with this form of urothelial carcinoma, and we have worked expeditiously to develop BALVERSA for patients in close consultation with the FDA.
“We look forward to the continued development of BALVERSA to understand how this important new therapy may further inform the care of patients with metastatic urothelial carcinoma and its investigational use in other cancers where FGFR alterations may be present in the future.”
Balversa is an oral fibroblast growth factor receptor (FGFR) kinase inhibitor, which was granted the FDA breakthrough therapy designation in March 2018, followed by priority review designation of its new drug application in September 2018.
Its accelerated approval was based on a phase 2 trial that featured 87 patients having locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had advanced after treatment with chemotherapy.
In the single-arm study called BLC2001 that evaluated the drug’s efficacy, the overall response rate in the enrolled patients was 32.2%, with 2.3% having a complete response and nearly 30% showing a partial response.
FDA center for drug evaluation and research office of hematology and oncology products acting director Richard Pazdur said: “We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types.
“Today’s approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
“FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs.”