FDA hits pause on novel radiation therapy's approval
The U.S. Food and Drug Administration has halted the approval process of a promising new radiation therapy treatment.
Developed by Vivos Inc., Radiogel is a novel hydrogel-based radioactive therapy designed to treat solid tumors. It is comprised of highly insoluble, microscopic, (< 2.0 µm diameter), yttrium-90 phosphate, (90YPO4), crystalline particles suspended in a sterile phosphate-buffered saline-polymer “gel” that is kept at room temperature. It is injected directly and uniformly into tumors, maximizing radiation dose to a specific area of interest while sparing healthy surrounding tissue.
Radiogel previously earned the FDA’s Breakthrough Device Designation due to its potential to treat certain cancers. However, after its recent 30-day review process, the FDA declined the product’s Investigational Device Exemption (IDE) application, pausing its track to human trials in the U.S., which were set to take place at Mayo Clinic.
Vivos submitted IDE application to the FDA in July. At that time, the company’s CEO, Dr. Michael Korenko, expressed optimism for the treatment’s potential.
“This is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA,” Korenko said in a release. “The strong evidence of RadioGel’s safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need.”
The therapy was stopped short of approval 30 days later. Despite this, Vivos has expressed their intentions to continue to trek forward.
“We are now focused on addressing the items we received in the FDA letter and will have an initial call with the FDA within 10 days as provided in the FDA correspondence. We also intend to participate in a pre-sub meeting with the FDA review team in the coming weeks, with the goal of resubmitting the application for the IDE.” Korenko noted. “Radiogel received the FDA Breakthrough Device Designation and has demonstrated an unparalleled therapeutic ratio and strong safety profile. Vivos remains committed to pursuing approval for Radiogel in the US market.”
Once the IDE is approved, human clinical trials in the U.S. can begin.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.