The FDA has decided to re-evaluate the ProSense System as a minimally invasive treatment option for patients with early-stage, low-risk breast cancer.
Following its initial rejection, the ProSense System, a minimally invasive approach for the treatment of early-stage, low-risk breast cancer, will undergo a detailed FDA review under 21 CFR 10.75.1
The ProSense System is a cryoablation technology that works by destroying tumors through freezing. It is an alternative approach to surgical tumor removal among patients with early-stage breast cancer as it utilizes liquid nitrogen's chilling power, creates precise lethal zones, and minimizes damage to surrounding healthy tissue. ProSense offers a minimally invasive option for treating various tumors, including those in the breast, kidney, lung, and liver.
In addition to the FDA determining there to be sufficient basis to reopen the de novo file, they have also requested that IceCure submit the full 5-year dataset from the ICE3 trial. With the final patient in the ICE3 study expected to complete a 5-year follow up examination by the end of February 2024, the company plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024.
"The FDA has set a very clear path to clearance for ProSense® in early-stage breast cancer, which may lead to women having a new, minimally invasive, safe, and effective treatment option," said Eyal Shamir, chief executive officer of IceCure, in a press release. "We remain hopeful that final ICE3 data will be in line with our interim results and are confident that we can deliver the dataset, comparable analysis, and real-world data to the FDA in the next few months."
The FDA has also requested that the company submit an analysis of the ICE3 results and how they compare with findings from the LUMINA study (NCT01791829), a study sponsored by the Ontario Clinical Oncology Group in Canada, which assessed the risk of recurrence among patients with low-risk luminal A breast cancer. Those included in this study were treated with lumpectomy surgery with adjuvant hormone therapy.
IceCure also was invited to submit real-world data from the use of ProSense across the globe from the FDA. This includes data on its post-market commercial use in territories where ProSense is already approved for the treatment of breast cancer and data from independent third-party studies.
A request to review de novo classification for ProSense under 21 CFR 10.75 was filed to the FDA for the treatment of patients with early-stage, low-risk breast cancer in November 2023. Interim data from the ICE3 breast cancer study support the FDAs decision to re-evaluate the ProSense system.
ICE3, the largest controlled, multi-location trial evaluating liquid-nitrogen-based cryoablation, is assessing ProSense in malignant breast tumors that are small, low-risk, and early-stage.2 The trial followed 82 patients with breast cancer for 5 years with a total of 194 patients eligible for cryoablation across 19 hospitals in the United States, including Columbia University Medical Center and Mount Sinai Beth Israel.
As of July 2022, the recurrence-free survival was 96.91% as 188 patients of the 194 eligible did not have a cancer recurrence. The procedure was also 100% safe, and no significant divide-related adverse event or complications were reported. Further, there was no scarring or change to the shape or size of the breast.