FDA approves Balversa for metastatic urothelial carcinoma
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The FDA approved erdafitinib for certain adults with locally advanced or metastatic urothelial carcinoma.
The indication applies to use of the agent by patients whose disease progressed during or after one line of prior systemic therapy, and who have susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations detected by an FDA-approved companion diagnostic test.
This approval amends a prior accelerated approval, which authorized use of the agent by patients with metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 alterations previously treated with platinum-containing chemotherapy.
Erdafitinib (Balversa, Janssen) is a small molecule inhibitor of FGFR.
The FDA based approval on results of Study BLC3001 Cohort 1, a randomized open-label trial that included 266 patients with metastatic urothelial carcinoma.
Eligible participants had selected FGFR3 alterations and been treated with one or two prior systemic therapies, including PD-1 or PD-L1 inhibitors.
Researchers randomly assigned study participants 1:1 to erdafitinib or investigator’s choice of chemotherapy (docetaxel or vinflunine).
Results showed improved OS (median, 12.1 months vs. 7.8 months; HR = 0.64; 95% CI, 0.47-0.88) and PFS (median, 5.6 months vs. 2.7 months; HR = 0.58; 95% CI, 0.44-0.78) in the erdafitinib group. Four times as many patients in the erdafitinib group responded to treatment (35.3% vs. 8.5%; P < .001).
Adverse events reported among at least 20% of erdafitinib-treated patients 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, fatigue, dry skin, constipation, decreased appetite, alopecia, dry eye and weight loss.
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