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- Title
Clinical Evidence and Selecting Patients for Treatment with Erdafitinib in Advanced Urothelial Carcinoma.
- Authors
Sayegh, Nicolas; Tripathi, Nishita; Agarwal, Neeraj; Swami, Umang
- Abstract
Erdafitinib received accelerated approval on April 12, 2019, for patients with metastatic or locally advanced urothelial carcinoma with susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations and who have progressed during or following at least one platinum-based chemotherapy. It thus became the first-ever targeted therapy to receive accelerated FDA approval for metastatic bladder cancer. In the BLC2001 trial, erdafitinib demonstrated an overall response rate of 40% in patients with urothelial carcinoma. Common adverse events include hyperphosphatemia and retinopathy and require regular monitoring. While the increase in serum phosphate levels has been determined to be a pharmacodynamic marker of response, further interrogation of other clinical, genomic, and transcriptomic biomarkers is warranted. Results of the ongoing Phase III trial, THOR, which is comparing erdafitinib to the standard of care (chemotherapy or immunotherapy), are expected to confer full approval. Establishing guidelines for optimal erdafitinib sequencing with immunotherapy and other approved targeted therapies (enfortumab vedotin and sacituzumab govitecan) remains an unmet need.
- Subjects
UNITED States. Food &; Drug Administration; TRANSITIONAL cell carcinoma; FIBROBLAST growth factor receptors; BLADDER cancer; CLINICAL trials
- Publication
OncoTargets & Therapy, 2022, Vol 15, p1047
- ISSN
1178-6930
- Publication type
Article
- DOI
10.2147/OTT.S318332