FDA Requests More Data After Reviewing IsoRay’s Application for GammaTile Radiation Therapy

FDA Requests More Data After Reviewing IsoRay’s Application for GammaTile Radiation Therapy

IsoRay, a company specializing in the treatment of prostate and other cancers, has received a response from the U.S. Food and Drug Administration (FDA) regarding the company’s pending 510(k) application for its GammaTile radiation therapy system.

Following a review, the FDA said IsoRay and its co-applicant GammaTile needed to submit additional data within the next 180 days as a condition of securing FDA clearance for the GammaTile device.

A 501(k) application, or premarket notification, is required by the FDA of all medical device manufacturers of their plans to market a device at least 90 days in advance. The FDA determines whether the device is new or equivalent to one already on the market so that it can be properly classified.

The GammaTile radiation therapy system uses IsoRay’s proprietary Cesium-131 radiation seeds, which are embedded in a collagen “tile” and placed in surgical margins at the time of surgery, enabling very elevated doses of radiation to be precisely delivered to targeted tissue without damaging the surrounding areas. This therapeutic approach is called brachytherapy.

Through an alliance with the Barrows Neurological Institute in the United States, more than 80 patients have already been treated with GammaTile in clinical trials over the last five years. Results point to an extension of a median time to recurrence with a very low rate of side effects, the company reported in a press release.

According to IsoRay, brachytherapy has several advantages for patients. The therapy is very specific for treating solid mass tumors; is able to direct the radiation treatment where it will be most beneficial, limiting dose to surrounding tissues; and is minimally invasive, meaning there is no surgical incision, leading to a shorter recovery time.

In addition, brachytherapy is one of the most cost-effective treatment options available. It is administered a single time and is customized for each case. It also allows for other parallel treatment options, including radiation, cryosurgery, and hormonal therapy.

Disadvantages of brachytherapy include the fact that it’s generally performed under general anesthesia, with the typical potential side effects. Also, it may require limited prolonged contact with others right after treatment to limit dose to healthy individuals.

The treatment may also induce side effects like urinary and rectal complications, as well as limitations in sexual function, and it’s only indicated for very targeted treatments, so if your disease is not in your treatment zone, it may not be effective.

Due to the extra time that IsoRay will need to dedicate to comply with the FDA’s request in the 510(k) submission response, a pending New-Technology Add-On Payment (NTAP) application, which requires an FDA-cleared product, will also need to be rescheduled and is planned to be resubmitted in the fall of 2017 to be included in the next annual review cycle.

“This is a good outcome for the novel GammaTile product,” said Tom LaVoy, IsoRay’s chairman and CEO. “With the completion of additional testing anticipated by the end of 2017, we project potential 510(k) clearance of the GammaTile product in the first half of 2018, which would allow for the NTAP application to be approved in 2018 during the annual review process.”

“GammaTile addresses a large unmet clinical need for the treatment of recurrent brain tumors and we’re pleased to be advancing on the path to commercialization of this important product,” he said.

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