The FDA Has Approved A New Cancer Treatment From The University of Maryland

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A new kind of breast cancer therapy technology, produced at the University of Maryland School of Medicine, won approval from the U.S. Food and Drug Administration to be brought to market and will be used to treat patients at the school’s affiliated Baltimore hospital.

The GammaPod was invented by Cedric X. Yu, a clinical professor of radiation oncology at the School of Medicine, and William F. Regine, chief of radiation oncology at the Marlene and Stewart Greenebaum Comprehensive Cancer Center. It has been in development for nearly 10 years and is backed by a $3 million grant from the National Institutes of Health. A prototype has been tested at the University of Maryland Medical Center and the system was granted 501(k) FDA clearance in late December. The clearance signals the device being brought to market is satisfyingly as safe and effective.

The technology uses stereotactic radiation therapy, which delivers a high-dose of radiation directly to a tumor without affecting nearby healthy tissue. The GammaPod system targets a tumor with thousands of precisely focused beams of radiation from 36 rotating sources. Treatments can take five to 40 minutes each and patients commonly require fewer sessions of stereotactic radiation.

Regine said his hope is that the radiation therapy can “change the paradigm” for treating early-stage breast cancer and cut down on the need for patients to undergo surgery,

“We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel,” Yu said in a statement. “This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”

Yu is CEO of Xcision Medical Systems LLC, which manufactures the GammaPod.

University of Maryland School of Medicine investigators submitted data from 15 patients treated with the GammaPod in a feasibility and safety study, as part of the FDA review process. Patients received a single “boost” treatment with GammaPod to the site where a tumor was removed, along with three weeks of traditional radiation treatments to the whole breast. The total regimen was reduced by three to four sessions, compared to traditional treatments.

In further clinical trials, researchers will investigate ways to use the GammaPod before and after surgery, to gauge effectiveness in reducing the size of a tumor before removal, or giving a sufficient dose to destroy it

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