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FDA Approves Qiagen Companion Dx for Bladder Cancer Drug Balversa

NEW YORK (GenomeWeb) – The US Food and Drug Administration announced today it  approved Qiagen's Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic for Janssen Pharmaceutical's metastatic bladder cancer drug erdafitinib (Balversa) in a molecularly defined subpopulation.

Erdafitinib garnered accelerated approval as a treatment for adult advanced bladder cancer patients who have progressed on plantinum-based chemotherapy and who harbor alterations in FGFR3 or FGFR2 genes. It is the first targeted treatment that the FDA has approved for bladder cancer patients with FGFR alterations.

Qiagen's test is intended to identify individuals with these alterations who are likely to respond to erdafitinib. FGFR alterations are present in 1 in 5 advanced bladder cancer patients.

Separately, Qiagen today announced the US launch of the test as a CDx for the drug. The therascreen FGFR Kit will run on QIAGEN’s Rotor-Gene Q MDx, which leverages a worldwide exclusive license for in vitro diagnostic use of FGFR3:TACC3 fusions from Columbia University. "The new therascreen FGFR Kit ... will be available through QIAGEN’s Day-One Lab Readiness program to accelerate the availability of innovations in Precision Medicine," Thierry Bernard, senior VP and head of QIAGEN’s Molecular Diagnostics Business Area, said in a statement.

"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," Richard Pazdur, director of the FDA's Oncology Center for Drug Evaluation and Research, said in a statement.

The FDA reviewed data from a study involving 87 patients with locally advanced or metastatic bladder cancer and FGFR3 or FGFR2 alterations to approve erdafitinib. The overall response rate was 32.2 percent, with 2.3 percent of patients experiencing a complete response and around 30 percent having a partial response. The average response to the drug was five-and-a-half months.

Around 25 percent of patients in the study received an anti-PD-1 or -PD-L1 drug previously. Patients who hadn't responded to these immunotherapeutics responded to erdafitinib.

The FDA noted that the drug may cause serious eye problems, such as inflamed cornea and disorders of the retina. The agency advises patients to have eye examinations intermittently and to immediately inform their doctors if they have loss of vision or blurry eyesight. The agency also told healthcare professionals to check patients' blood phosphate levels between 14 and 21 days after starting treatment and monthly, and to increase the dose of erdafitinib if patients' serum phosphate is below the target level. The drug is contraindicated in pregnant women and men receiving treatment should use effective contraception.