FDA Grants Breakthrough Device Status to Alpha DaRT for SCC

The FDA granted Alpha Tau Medical a Breakthrough Device Designation for Alpha DaRT for the treatment of squamous cell carcinoma of the skin and oral cavity without curative standard of care.

The U.S. Food and Drug Administration (FDA) granted Alpha Tau Medical a Breakthrough Device Designation for Alpha DaRT for the treatment of squamous cell carcinoma (SCC) of the skin and oral cavity without curative standard of care.

Alpha Tau submitted data to the FDA supporting this designation, including a pilot clinical study of Alpha DaRT treatment of SCC of the skin, head and neck, in which almost 80 percent of the lesions showed a complete response, and 100 percent demonstrated a partial or complete response, alongside a mild safety profile.

"The FDA's recognition of the Alpha DaRT as a Breakthrough Device is a tremendous milestone for the company, as we seek to bring our revolutionary technology to patients in need," says Alpha Tau CEO Uzi Sofer, in a news release. "This confirms our long-standing hopes and expectations for this product, and comes at the perfect time to accelerate our clinical trial program that is moving ahead rapidly now in the U.S."

Alpha Tau Chief Medical Officer Dr. Robert Den adds, "This achievement was the result of the dedication and hard work of the entire Alpha Tau team. While we are motivated by our mission to help every patient possible, it is exciting and gratifying to see external recognition of our vision of clinical excellence."

To speed access to essential new medical technologies, a Medicare coverage pathway called Medicare Coverage of Innovative Technology stands to provide FDA Breakthrough Devices with Medicare coverage for 4 years following FDA marketing authorization.

In preclinical studies using Alpha DaRT, a response was observed in all tested solid tumors, including pancreatic, lung, breast, and prostate tumor cells. These cancers and others will be investigated as part of the Alpha DaRT clinical trial program, which includes a skin cancer feasibility trial currently ongoing at Memorial Sloan Kettering Cancer Center in New York and other sites across the U.S.