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FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma

Bladder cancer.

Erdafitinib (Balversa™, Janssen Pharmaceutical Companies) was recently granted FDA approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Erdafitinib targets genetic alterations that occur in FGFRs, which regulate important biological processes, including cell growth and division, during development and tissue repair.

To be a candidate for erdafitinib, patients must be selected via an FDA-approved companion diagnostic. One diagnostic tool—the therascreen® FGFR RGQ RT-PCR Kit, developed by QIAGEN—was also recently approved to be used to determine if patients qualify for erdafitinib.

Approval was granted based on a multicenter, open-label, single-arm study enrolling 87 patients with locally advanced or metastatic urothelial carcinoma that had progressed on or after at least one prior chemotherapy and had certain FGFR3 gene mutations or FGFR2 or FGFR3 gene fusions. Erdafitinib was administered at a starting dose of 8 mg once daily, with an increase to 9 mg daily in patients whose serum phosphate levels were below 5.5 mg/dL, between days 14 and 17. The dose increase was administered to 41% of the patients.

Erdafitinib produced an objective response rate of 32.2%, with complete responses occurring in 2.3% of patients and partial responses occurring in 29.9% of patients. The median response duration was 5.4 months.

Ocular disorders, such as central serous retinopathy or retinal pigment epithelial detachment, occurred in 25% of patients. Other common side effects reported in at least 40% of patients included increased serum phosphate, stomatitis, fatigue, increased serum creatinine, diarrhea, dry mouth, onycholysis, increased alanine aminotransferase, increased alkaline phosphatase, and decreased sodium.

"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," commented Richard Pazdur, MD, Director of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

For More Information

Clinicaltrials.gov (2019). An efficacy and safety study of JNJ-42756493 in participants with urothelial cancer. NLM identifier: NCT02365597. 

Image Courtesy of Creative Commons. Licensed Under CC BY-SA 3.0

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