FDA Grants Breakthrough Device Designation For RefleXion’s Lung Cancer Radiotherapy

The FDA has given Breakthrough Device Designation to therapeutic oncology company RefleXion Medical for its biology-guided radiotherapy (BgRT), which is used to treat lung tumors. BgRT is revolutionary in that it has pioneered the utilization of injected radiotracers for the immediate treatment of moving tumors. These radiotracers give off active signals, known as emissions, that set guidance points for treatment delivery.

“Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs,” said Terence Williams, M.D., Ph.D., Chair of Radiation Oncology at City of Hope Comprehensive Cancer Center. “The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies.”

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Around a quarter of all cancer-related deaths in the U.S. stem from lung cancer, and the lungs are statically proven to be the most prevalent location of metastatic tumors spurred by cancer in other parts of the body. RefleXion's intention for BgRT is to augment overall treatment options for patients in any stage of their cancer. Even though existing technology cannot reach more than one to three tumors, recent clinical trials for lung cancer which fuse drug therapy with radiology have shown vast improvements in progression-free survival rates. BgRT will hopefully jump this hurdle in order to deliver radiotherapy to additional sites of disease, thereby bettering outcomes for patients with advanced cancers.