Dr. Sonpavde on Accelerated Approval of Erdafitinib in Bladder Cancer

Guru Sonpavde, MD
Published: Thursday, May 02, 2019



Guru Sonpavde, MD, director of Bladder Cancer at Dana-Farber Cancer Institute, discusses the FDA accelerated approval of erdafitinib (Balversa) in bladder cancer.

On April 12, 2019, the FDA granted an accelerated approval to erdafitinib for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. The FDA approved the agent in conjunction with a companion diagnostic device calledQIAGEN therascreen® FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit.

The approval is based on data from the phase II BLC2001 trial, in which erdafitinib resulted in an overall response rate of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic disease. The median age of patients enrolled in the trial was 67 years, the majority of whom were white and male. Ninety-two percent of patients had an ECOG performance status of 0 or 1 and 66% had visceral metastases. The median duration of response with the agent hovered around the 6-month mark, says Sonpavde. Erdafitinib is now the first biologic targeted therapy to be approved for use in patients with metastatic bladder cancer, he adds.
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Guru Sonpavde, MD, director of Bladder Cancer at Dana-Farber Cancer Institute, discusses the FDA accelerated approval of erdafitinib (Balversa) in bladder cancer.

On April 12, 2019, the FDA granted an accelerated approval to erdafitinib for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. The FDA approved the agent in conjunction with a companion diagnostic device calledQIAGEN therascreen® FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit.

The approval is based on data from the phase II BLC2001 trial, in which erdafitinib resulted in an overall response rate of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic disease. The median age of patients enrolled in the trial was 67 years, the majority of whom were white and male. Ninety-two percent of patients had an ECOG performance status of 0 or 1 and 66% had visceral metastases. The median duration of response with the agent hovered around the 6-month mark, says Sonpavde. Erdafitinib is now the first biologic targeted therapy to be approved for use in patients with metastatic bladder cancer, he adds.



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