It uses a special kind of immune cell called a regulatory T cell, or Treg.
Tregzi is for adults with certain high-risk blood cancers who are getting a stem cell transplant from a donor.
It is the first treatment to use Treg cells and stem cells from a closely matched donor together. The goal is to help the transplant go well while lowering the risk of a problem called chronic graft-versus-host disease (GVHD). GVHD is a common problem after a donor stem cell transplant. It happens when the donor’s immune cells attack the healthy tissue of the person who got the transplant. GVHD can range from mild to life-threatening. It may affect the skin, liver, stomach, intestines, and other organs. Acute GVHD usually starts within the first few months after a transplant. Chronic GVHD usually starts later. It can affect several organs for months or years. Preventing chronic GVHD is important. It helps people recover better and have a better quality of life after a transplant.
Why Was It Approved?
The FDA’s approval was based on a clinical trial of 187 adults with blood cancers, including leukemia or myelodysplastic syndrome. All of them had a matched donor transplant after pretransplant treatment. After one year, about 80% of the patients who got Tregzi were alive without chronic GVHD. This compares to about 40% of patients who got a standard stem cell transplant. Serious chronic GVHD developed in about 13% of patients who got Tregzi compared to 44% of patients who got a standard transplant.
What Do I Need to Know?
Tregzi is made just for you, using cells from your matched donor. You get two infusions on the day of your transplant, and another infusion two to three days later. All doses are given into a vein at a transplant center. You will also get pretransplant treatment before you receive Tregzi.
