Erdafitinib full approval offers hope for locally advanced/metastatic urothelial cancer
For patients with locally advanced or metastatic urothelial (bladder) cancer, available treatment options after initial response to first-line therapy are limited. Around 20% of patients with bladder cancer have mutations in the fibroblast growth factor receptor 3 (FGFR3) gene, and many suffer relapse. Now, the phase III THOR open-label clinical trial reports overall survival and response rate improvements with erdafitinib (Balversa) in patients with FGFR3 mutations and locally advanced or metastatic urothelial cancer. In this multicentre phase III trial, patients who had experienced disease progression on at least one prior systemic therapy (including a PD-1 or PD-L1 inhibitor) were randomly assigned to either erdafitinib or investigator’s choice of chemotherapy (either docetaxel or vinflunine) [Cohort 1]. In Cohort 2, patients were randomized to erdafitinib or pembrolizomab after receiving one previous treatment that did not contain an anti-PD-1 agent. Clinically and statistically significant improvements in median overall survival (12.1 versus 7.8 months), progression-free survival (5.6 versus 2.7 months) and objective response rate (35.3% versus 8.5%) were noted for erdafitinib compared with chemotherapy. This full approval based on Cohort 1 data follows accelerated approval of erdafitinib in 2019. Erdafitinib is the first oral FGFR inhibitor to offer promise for 20% of patients with FHFR3 mutations who, until now, have had limited options when disease progresses following therapy.
READ THE ARTICLE – https://ascopost.com/news/january-2024/fda-approves-erdafitinib-for-locally-advanced-or-metastatic-urothelial-carcinoma/