Janssen’s Balversa becomes first FDA-approved FGFR kinase inhibitor for advanced bladder cancer

pharmafile | April 15, 2019 | News story | Sales and Marketing Balversa, Cancer, FDA, Janssen, bladder cancer, pharma 

Janssen’s Balversa (erdafitinib) has become the first FDA-approved fibroblast growth factor receptor (FGFR) kinase inhibitor after the US agency authorised the therapy for the treatment of advanced bladder cancer.

Specifically, the approval covered the use of the drug in locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 or FGFR2 genetic alterations in patients whose disease has progressed following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Phase 2 data submitted in support of the application demonstrated that Balversa generated an objective response rate (ORR) of 32.2% as determined by the Blinded Independent Review Committee, with responding patients including those who had previously not responded to anti PD-L1/PD-1 therapy. Additionally, median duration of response (DoR) was recorded as 5.4 months.

However, it was noted that Balversa produced no confirmed responses in the FGFR2 fusion patient population.

 “I’ve spent my career specialising in the care of patients with metastatic urothelial carcinoma and understand the need for new treatments for this disease,” said Dr Arlene O Siefker-Radtke, lead study investigator and Professor of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center. “Balversa is an important new therapy for this small subset of patients with urothelial carcinoma who, up until now, had limited treatment options.”

The approval of Balversa was also accompanied by the marketing authorisation of the Qiagen therascreen FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit, which became the first FDA-approved diagnostic test to detect FGFR alterations.

“We recognise the significant unmet need that persists in the treatment 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,” said Dr Peter Lebowitz, Global Therapeutic Area Head, Oncology at Janssen. “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.”

Matt Fellows

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