FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

发布时间： 2024-01-26 阅读：292次

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January 19, 2024 -- the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. 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. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.

Efficacy was evaluated in Study BLC3001 Cohort 1, a randomized, open-label trial of 266 patients with mUC harboring selected FGFR3 alterations who had received 1-2 prior systemic treatments, including a PD-1 or PD-L1 inhibitor. Patients were randomized 1:1 to receive erdafitinib or investigator’s choice of chemotherapy (docetaxel or vinflunine). The major efficacy outcome measure was overall survival (OS). Investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were additional outcome measures.

Statistically significant improvements in OS, PFS, and ORR were demonstrated for erdafitinib compared with chemotherapy. Median OS was 12.1 months (95% CI: 10.3, 16.4) for patients who received erdafitinib and 7.8 months (95% CI: 6.5, 11.1) for those who received chemotherapy (hazard ratio [HR] 0.64 [95% CI: 0.47, 0.88]; p-value=0.0050). Median PFS was 5.6 months (95% CI: 4.4, 5.7) for patients who received erdafitinib and 2.7 months (95% CI: 1.8, 3.7) for those who received chemotherapy (HR 0.58 [95% CI: 0.44, 0.78]; p-value=0.0002). Confirmed ORR was 35.3% (95% CI: 27.3, 43.9) for those who received erdafitinib and 8.5% (95% CI: 4.3, 14.6) for those who received chemotherapy (p-value<0.001).