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Thomas Flaig, MD

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Erdafitinib Granted FDA Approval in Locally Advanced or Metastatic Urothelial Cancer

By: JNCCN 360 Staff
Posted: Tuesday, January 23, 2024

On January 19, the U.S. Food and Drug Administration (FDA) approved the FGFR inhibitor erdafitinib (Balversa) for adults who have locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations that has progressed on or after at least one line of prior systemic therapy. These genetic alterations are determined by an FDA-approved companion diagnostic test. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

The efficacy of erdafitinib was evaluated in Study BLC3001 (THOR; ClinicalTrials.gov identifier NCT03390504) Cohort 1. This randomized, open-label trial focused on 266 patients who had locally advanced or metastatic urothelial carcinoma and harbored selected FGFR3 alterations; they had received one to two prior systemic treatments, including a PD-1 or PD-L1 inhibitor. Patients were randomly assigned 1:1 to receive erdafitinib or investigator’s choice of chemotherapy (docetaxel or vinflunine). FGFR3 alterations were identified from tumor tissue in 75% of patients.

Statistically significant improvements in overall survival, progression-free survival, and objective response rate were demonstrated for erdafitinib compared with chemotherapy. Median overall survival was 12.1 months (95% confidence interval [CI] = 10.3–16.4 months) with erdafitinib and 7.8 months (95% CI = 6.5–11.1 months) with chemotherapy (hazard ratio [HR] = 0.64, 95% CI = 0.47–0.88, P = .0050). Median progression-free survival was 5.6 months (95% CI = 4.4–5.7 months) with erdafitinib and 2.7 months (95% CI = 1.8–3.7 months) with chemotherapy (HR = 0.58, 95% CI = 0.44–0.78, P = .0002). The confirmed objective response rate was 35.3% (95% CI = 27.3%–43.9%) with erdafitinib and 8.5% (95% CI = 4.3%–14.6%) with chemotherapy (P < .001).

The most common (occurring in > 20% of patients receiving erdafitinib) adverse reactions were 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 decreased weight.

The recommended erdafitinib dose is 8 mg orally once daily, with a dose increase to 9 mg once daily based on tolerability at 14 to 21 days.


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