FDA Oks Erdafitinib for Advanced Bladder Cancer

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The FDA has approved erdafitinib for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 alterations.

  • Erdafitinib (Balversa) has been approved the FDA for the treatment of locally advanced or metastatic urothelial carcinoma (UC) with FGFR3 alterations with disease progression following a prior line of treatment.1
  • The approval is supported by findings from the THOR study (NCT03390504).
  • Erdafitinib led to statistically significant improvements in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).

The FDA has approved erdafitinib, a kinase inhibitor, in locally advanced or metastatic UC with FGFR3 genetic alterations who have experienced disease progression on or following at least 1 prior line of treatment. The approval is supported by findings from the phase 3 THOR study.1

Statistically significant improvements in OS, PFS, and ORR were observed in the study. The median OS was 12.1 month (95% CI, 10.3-16.4) for patients who received erdafitinib vs 7.8 month (95% CI, 6.5-11.1) in patients who received chemotherapy (HR, 0.64; 95% CI, 0.47-0.88; P =.0050). The median PFS was 5.6 months (95% CI, 4.4-5.7) with erdafitinib vs 2.7 months (95% CI, 1.8-3.7) with chemotherapy (HR, 0.58; 95% CI, 0.44-0.78; P =.0002). The confirmed ORR was 35.3% (95% CI, 27.3%-43.9%) with erdafitinib compared with 8.5% (95% CI, 4.3%-14.6%) with chemotherapy (P <.001).

"We now have level 1 evidence showing that erdafitinib improves survival, and it can help extend patient's lives. We certainly are not curing most patients with your urothelial cancer, but we are changing the outcomes and patients are living longer as a result of these targeted therapies that we are able to offer them," Arlene O. Siefker-Radtke, MD, professor of genitourinary medical oncology at the University of Texas MD Anderson Cancer Center in Houston, Texas, told Targeted Oncology.

Arlene O. Siefker-Radtke, MD

Arlene O. Siefker-Radtke, MD

The study’s primary end point was OS, and secondary end points included PFS, ORR, time until symptom deterioration, duration of response, incidence of adverse events (AEs), and oral clearance of erdafitinib.2

Regarding safety, the most common (>20%) AEs observed included increased phosphate, nail disorders, diarrhea, stomatitis, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased sodium, increased creatinine, dry mouth, decreased phosphate, palmar-plantar erythrodysesthesia syndrome, dysgeusia, fatigue, dry skin, constipation, decreased appetite, increased calcium, alopecia, dry eye, increased potassium, and weight loss.1

Erdafitinib is administered as an 8-mg oral dose once daily until disease progression or unacceptable toxicity, and the dose can be increased to 9 mg if tolerated at 14 to 21 days. Erdafitinib is not recommended for patients who are eligible for and have not received treatment with a PD-1 or PD-L1 inhibitor.

"Much of my career has been focused on caring for patients with metastatic urothelial carcinoma and generating research that emphasizes new, more personalized treatment approaches. The phase 3 THOR study, on which this approval is based, was designed to identify a subset of patients most likely to benefit from erdafitinib. For the estimated 1 in 5 patients with locally advanced bladder cancer who have an FGFR genetic alteration, erdafitinib offers another treatment option," added Siefker-Radtke.

REFERENCES:
1. FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma. News release. U.S. Food & Drug Administration. January 19, 2024. Accessed January 19, 2024. http://tinyurl.com/3cv6d3ax
2. A study of erdafitinib compared with vinflunine or docetaxel or pembrolizumab in participants with advanced urothelial cancer and selected fibroblast growth factor feceptor (FGFR) gene aberrations (THOR). ClinicalTrials.gov. Updated January 3, 2024. Accessed January 19, 2024. https://clinicaltrials.gov/study/NCT03390504

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