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Dr. Siefker-Radtke on Next Steps With Erdafitinib in Bladder Cancer

Arlene O. Siefker-Radtke, MD
Published: Friday, Aug 31, 2018



Arlene O. Siefker-Radtke, MD, professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses next steps with erdafitinib in patients with bladder cancer.

In March 2018, the FDA granted a breakthrough therapy designation to the oral pan-FGFR tyrosine kinase inhibitor (TKI) erdafitinib for the treatment of patients with metastatic bladder cancer. This designation was based on findings from a phase II study, which showed that more than 40% of patients with metastatic or unresectable bladder cancer responded to treatment with erdafitinib. Of the 99 patients on the trial, 40 responded to treatment, and an additional 39 patients had stable disease.

As a result of these findings, there are plans for a large phase III trial. This trial will explore the question of whether patients with FGFR-altered tumors respond differently to an FGFR-targeted therapy compared to immunotherapy. Patients who have not had prior immunotherapy will be randomized to either immunotherapy or erdafitinib. Patients who have had prior immunotherapy will be randomized to either erdafitinib, or a single-agent taxane or vinflunine, depending on location.


Arlene O. Siefker-Radtke, MD, professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses next steps with erdafitinib in patients with bladder cancer.

In March 2018, the FDA granted a breakthrough therapy designation to the oral pan-FGFR tyrosine kinase inhibitor (TKI) erdafitinib for the treatment of patients with metastatic bladder cancer. This designation was based on findings from a phase II study, which showed that more than 40% of patients with metastatic or unresectable bladder cancer responded to treatment with erdafitinib. Of the 99 patients on the trial, 40 responded to treatment, and an additional 39 patients had stable disease.

As a result of these findings, there are plans for a large phase III trial. This trial will explore the question of whether patients with FGFR-altered tumors respond differently to an FGFR-targeted therapy compared to immunotherapy. Patients who have not had prior immunotherapy will be randomized to either immunotherapy or erdafitinib. Patients who have had prior immunotherapy will be randomized to either erdafitinib, or a single-agent taxane or vinflunine, depending on location.



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