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FDA panel votes against ablation ultrasound treatment for prostate cancer

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An FDA advisory panel recently rejected high-focus ultrasound device as a treatment for low-risk, localized prostate cancer.

The ultrasound system (Ablatherm-HIFU, EDAP Technology) is intended to treat prostate cancer by ablating the entire prostate gland via high intensity focused ultrasound, which generates heat of around 200 degrees Fahrenheit. Currently, there are no other high intensity focused ultrasound devices on the market.

The FDA’s Gastroenterology & Urology Devices panel voted 9 to 0 on the system’s effectiveness, but voted 5 to 3 (with one abstention) against its safety, deciding the system did not demonstrate a favorable benefit-to-risk ratio by a vote of 8 to 1, with one abstention.

“We are disappointed by the Committee's recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialog during today's meeting,” Marc Oczachowski, chief executive officer of EDAP, said in a press release. “We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU's pre-market approval.”

Panel members noted that the primary endpoint, which evaluated the system’s noninferiority to cryotherapy after two years, was insufficient due to a shortened timeframe before prostate cancer would become fatal.