Alongside Janssen’s accelerated approval of Balversa as the first targeted therapy for metastatic bladder cancer, the FDA also greenlighted Qiagen’s companion diagnostic test to detect the relevant urothelial tumors with FGFR gene alterations.
Similarly groundbreaking, Qiagen’s therascreen PCR kit is the first diagnostic to receive approval for guiding FGFR-related therapies in any cancer indication. The German company has launched the test at a handful of initial laboratories through its “Day-One Lab Readiness program,” according to Thierry Bernard, head of Qiagen’s molecular diagnostics business.
The readiness program includes early workflow preparations, staff training and verification of the new molecular diagnostics required for today’s targeted cancer treatments. Earlier this month, Qiagen signed on LabCorp as a partner in the effort.
The therascreen kit will run on Qiagen’s Rotor-Gene Q MDx, part of its modular QIAsymphony family of automated instruments, and employs an exclusive license for in vitro diagnostic use from Columbia University.
As the first precision medicine approved in the indication, Balversa (erdafitinib) could potentially put Janssen and its parent Johnson & Johnson in the running for billion-dollar sales. The kinase inhibitor was approved for patients who previously received chemotherapy, and have advanced or metastatic bladder cancer with FGFR2 or FGFR3 genetic mutations.
According to the FDA, bladder cancer is the sixth most-common in the U.S., with about 15,000 newly diagnosed patients per year. FGFR alterations—or fibroblast growth factor receptor, which help regulate cell growth and division during tissue development and repair—are found in about 20% of patients with recurrent or refractory disease.
Balversa was given the go-ahead after a small, phase 2, single-arm study of 87 bladder cancer patients demonstrated an overall response rate of 32.2%, and delayed tumor progression or death by a median of 5.4 months. Data from the full study, including 12 patients that had not received chemotherapy, showed a median overall survival of 13.8 months.