Erdafitinib approved for advanced urothelial carcinoma
medwireNews: US patients with locally advanced or metastatic urothelial carcinoma with key mutations may now be treated with the pan-fibroblast growth factor receptor (FGFR) inhibitor erdafitinib as a second-line or later therapy.
Erdafitinib has been granted accelerated approval for the treatment of adults who have tested positive for a susceptible FGFR3 or FGFR2 genetic alteration using an FDA-approved diagnostic kit and have received at least one adjuvant or neoadjuvant platinum-containing chemotherapy regimen.
The announcement follows data from the open-label Study BLC 2001 of 87 patients who were given an initial dose of erdafitinib 8 mg/day, increasing to 9 mg/day for those with serum phosphate levels within target range on days 14–17 of treatment.
The objective response rate was 32.2% among the participants, including a complete response rate in 2.3%, and responses lasted for a median of 5.4 months.
The listed side effects of treatment include central serous retinopathy and retinal pigment epithelial detachment in 25% of patients, as well as serum phosphate and liver enzyme elevations, stomatitis, fatigue, and diarrhea.
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