Following the FDA’s denial of a de novo classification request of ProSense, citing concerns about the choice of comparator group used in the ICE3 trial, IceCure is working to identify a more representative comparator group.
A request to review de novo classification for ProSense under 21 CFR 10.75 has been filed to the FDA for the treatment of patients with early-stage, low-risk breast cancer.1
The review is regarding the agency's denial of the de novo classification request by IceCure Medical, the developer of ProSense, which was filed and given to the FDA in October 2022. Interim data from the ICE3 breast cancer study support the breakthrough indication of patients with early-stage (Luminal A T1 invasive), low-risk breast cancer at 5 years, the recurrence-free rate was 95.7%.
With 100% doctor and patient satisfaction with cosmetic results, these findings were included in the request with the hopes of making a breakthrough minimally-invasive cryoablation procedure available to women with breast cancer in the United States.
However, on September 20, 2023, it was announced that the FDA denied the de novo request based on the choice of comparator group in the trial against which the ICE3 interim data were assessed. The company is now working with the FDA to identify a more appropriate comparator group that further represents the patient population that the ProSense system aims to treat.
"We believe the appeal process allows us to work with the FDA to identify an appropriate comparator group and that a subsequent analysis of the data may support the granting of the de novo submission and marketing authorization," said Eyal Shamir, chief executive officer of IceCure Medical, in a press release.
A response to the appeal by IceCure is expected to be announced by the end of January 2024, according to the FDA.
The ICE3 study is the largest controlled, multi-location trial to be done evaluating liquid-nitrogen–based cryoablation of malignant breast tumors that are small, low-risk, and early-stage without removing them.2 ProSense cryoablation is a minimally invasive, non-surgical, procedure that is done outpatient and takes 40 minutes. Only a local 1% lidocaine injection is required for the procedure.
The trial followed 82 patients with breast cancer for 5 years, according to results from the interim analysis performed in July 2022. A total of 194 patients were eligible for cryoablation across 19 hospitals in the United States, including Columbia University Medical Center and Mount Sinai Beth Israel.
As of July 2022, 188 patients of the 194 eligible did not have a cancer recurrence, and the procedure was 100% safe with no significant divide-related adverse event or complications reported. No scarring or change to the shape or size of the breast was reported.
It is anticipated that the ICE3 trial will be completed in the first quarter of 2024 after the last patients’ 5-year follow-up exam.1
The decision on this de novo classification request from the FDA for the treatment of breast cancer does not have any effect on the FDA cleared authorization of ProSense for other indications in the United States, and across these indications, patients continue to have access to and benefit from ProSense.
"Furthermore, we believe the wealth of published studies in the scientific literature, including meta-studies, offer proper comparator groups that demonstrate that ProSense is a minimally invasive alternative solution as compared to the current standard of care lumpectomy, in the breakthrough indication of early-stage, low-risk breast cancer patients," added Shamir in the release.1