Erdafitinib Approved by FDA in Metastatic Urothelial Carcinoma
Patients with metastatic urothelial carcinoma who are susceptible to FGFR3 gene alterations may now receive erdafitinib, according to the FDA.
The approval is based on findings from cohort 1 of the BLC3001 study (NCT03390504).
The News
The FDA has approved erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma who are susceptible to FGFR3 genetic alterations determined with an approved companion diagnostic, according to a press release from the agency.
Patients can receive the treatment if they have progressive disease after at least 1 line of therapy. If patients have not been given prior PD-1 or PD-L1 therapy, they should not receive erdafitinib.
The recommended dose of erdafitinib is 8 mg orally once daily with potential to increase to 9 mg once daily based on tolerability between days 14 and 21. Patients should continue treatment until disease progression or unacceptable toxicity.
Supporting Data
The approval is based on findings from cohort 1 of the BLC3001 study (NCT03390504).
The median overall survival (OS) was 12.1 months (95% CI, 10.3-16.4) in the erdafitinib arm vs 7.8 months (95% CI, 6.5-11.1) months in the chemotherapy arm (HR, 0.64; 95% CI, 0.47-0.88; P = .0050). The median progression-free survival (PFS) in the erdafitinib arm was 5.6 months (95% CI, 4.4-5.7) vs 2.7 months (95% CI, 1.8-3.7) in the chemotherapy arm (HR, 0.58; 95% CI, 0.44-0.78; P = .0002). In the erdafitinib group, the confirmed objective response rate (ORR) was 35.3% (95% CI, 27.3-43.9) vs 8.5% (95% CI, 4.3-14.6) in the chemotherapy group (P <.001).
The BLC3001 study
The trial enrolled 266 patients in the aforementioned population and included those who had received 1 to 2 lines of prior therapy. Patients were randomly assigned 1:1 to receive erdafitinib or chemotherapy.
The primary end points were OS, with secondary end points being PFS and ORR.
Safety Data
Common adverse effects in 20% or more of patients included increased phosphate, nail disorders, diarrhea, stomatitis, increased alkaline phosphatase, and decreased hemoglobin.
Reference
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma. News release. FDA. January 19, 2024. Accessed January 19, 2024. https://rb.gy/fqbfm6
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