A device used in Europe to treat prostate cancer with lower rates of erectile dysfunction raised concerns from U.S. regulators over data the company says shows it prevents the disease's return.
The device, called Ablatherm, is manufactured by EDAP TMS SA, a French company. It's an alternative to traditional surgical and radiation treatments, and uses a robotic arm to insert a high-intensity, focused ultrasound device that heats and kills cancer cells. The Food and Drug Administration said it will convene a panel of outside advisers on July 30 to discuss the risks and benefits of the device before the agency decides whether to approve it.
While the company claims Ablatherm produces lower rates of side effects than traditional treatments, the FDA questioned whether the device's effectiveness holds up, agency staff wrote in a report released today ahead of the advisory meeting.
"The clinical benefit of the subject device in the treatment of the low risk population is unclear," agency staff wrote in their report.
The majority of men who get surgery or radiation for prostate cancer suffer from immediate or delayed erectile dysfunction. Of patients who used Ablatherm, 30 percent to 40 percent of men treated with the device in the 14 years it has been used in Europe had erection problems, less than traditional treatments, EDAP Chief Executive Officer Marc Oczachowski said in a telephone interview.
FDA staff questioned EDAP's safety and effectiveness data because the company compared patients in two different studies to gather evidence, rather than a head-to-head trial.
EDAP relied on a registry of patients in Europe who have used Ablatherm, and compared their data to a subgroup of patients in a U.S. Department of Veterans Affairs trial who underwent surgery called radical prostatectomy.
EDAP's American depositary receipts fell 11 percent to $4.34 at 9:45 a.m. after falling as much as 12 percent, the largest intraday drop since June 2013.
The company's measurement of how long patients lived without their disease spreading falls short of the "gold standard" measurement of overall survival, FDA staff said. Patients who used Ablatherm had a 1.1 percent risk of their cancer spreading after eight years, compared to a 1.4 percent risk for men who underwent surgery, according to the FDA report.
Ablatherm is a probe connected to a robotic arm that is inserted through the rectum. A urologist watches an ultrasound of the patient's prostate, and the probe heats the tissue and kills cancer cells. Patients can get the procedure as outpatients, and it would be the first such device in the U.S. approved for the treatment of prostate cancer, Oczachowski said.
There are minimally invasive surgical techniques that make small incisions and use long instruments to remove the prostate, including Intuitive Surgical Inc.'s da Vinci robotic system, according to the American Cancer Society. Patients recover sexual function faster when doctors use the da Vinci robot versus traditional surgery, according to Intuitive.
Ablatherm has been used on 40,000 patients worldwide, Oczachowski said. EDAP generated 24.1 million euros ($32 million) in 2013 sales, the company reported.
Oczachowski hopes FDA approval, which is more stringent then Europe for medical devices, will give urologists, patients and insurance companies increased comfort with the device to boost use.
Prostate cancer is the second-most common cause of male cancer-related death in the U.S., according to the FDA. About 233,000 men will be diagnosed with prostate cancer this year and 29,480 will die from it, according to the National Institutes of Health. About 35 percent of prostate cancer patients undergo surgery, 45 percent receive radiation and the rest watch and wait, EDAP said in an investor presentation.
EDAP's target is for 100,000 U.S. patients a year to use high intensity focused ultrasound as a primary treatment, according to the presentation.