New CAR-T Cell Therapy Approved for Multiple Myeloma Patients
- The Food and Drug Administration has approved a second CAR-T cell therapy for multiple myeloma patients.
- The new drug, cilta-cel (sold as brand name: Carvykti), has been approved for the treatment of adults with multiple myeloma that has resisted treatment or has returned after four or more prior forms of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
- The new approval will further patient access to this revolutionary therapy something that has limited eligible patients from receiving CAR-T cell therapy in the past as there was previously only one CAR-T cell therapy (Abecma) approved by the FDA.
The U.S. Food and Drug Administration has approved a second CAR-T cell therapy for multiple myeloma patients. Multiple myeloma is a rare type of blood cancer. When you have this cancer, white blood cells called plasma cells (the cells that make antibodies to fight infections) in your bone marrow grow out of proportion to healthy cells. Those abnormal cells leave less room for the healthy blood cells your body needs to fight infections.
Read MoreDr. Shah says CAR-T is a good option for patients who have been heavily treated for multiple myeloma – those who’ve had three or more prior lines of therapy. (Lines of therapy means: one complete cycle of a single drug, a combination of several drugs, or a planned sequence of therapies.)
“…the best thing about CART therapy is that it’s a one time deal, they go get their cart and if they’re lucky they have a nice long remission where they don’t have to get other chemo,” she said.
The new FDA-approved drug, cilta-cel (sold as brand name: Carvykti, and made by Johnson & Johnson and Legend), has been approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
In the clinical trial setting, Carvykti exhibited a two-year progression free survival rate of 60% in heavily pre-treated patients and a two-year overall survival rate of 74%.
Before Carvykti, there was only one CAR-T cell therapy approved by the FDA to treat myeloma patients: Bristol Myers Squibb's idecabtagene vicleucel (brand name: Abecma). The drug was approved by the FDA in March 2021 and became the first CAR-T cell therapy available to treat myeloma patients with at least four previous lines of therapy, as well as patients who either did not respond to the treatment (refractory myeloma), or initially responded but then had their cancer return (relapsing myeloma). These parameters eliminate newly diagnosed patients, as they have only begun their treatment regimen.
Since Abecma was the only approved CAR-T, accessibility became a major hindrance for eligible patients; doctors sometimes have had a difficult time getting their patients this therapy since there was only one available, coupled with how long the process takes.
"We have one CAR-T approved, another one we expect to be approved shortly," Dr. James Hoffman, a hematologist focused on multiple myeloma and amyloidosis at the Sylvester Comprehensive Cancer Center at the University of Miami, told SurvivorNet in December. "So by the time someone's listening to this, there's likely to be more than one.
"The access is that's the problem," Dr. Brandon Blue, a hematologist and oncologist at Moffitt Cancer Center in Tampa, Fla., told SurvivorNet in November 2021. "So that's why hopefully another company (Johnson & Johnson and Legend) we're hoping in the next three to six months also gets FDA approved. So at least now there'll be two centers who can basically get this (CAR-T cell therapy)."
What is CAR-T Cell Therapy & How Does it Work?
Our immune system was designed to fight off foreign invaders such as viruses, bacteria and yes, cancer. Sometimes, cancer cells can evade detection and continue to grow. But CAR-T cell therapy essentially re-trains your immune system to make it a more efficient, and more effective, cancer fighter.
The process starts when your doctor intravenously removes a sample of your blood. With a procedure called leukapheresis the removal of blood to collect specific blood cells your blood flows into a machine that separates out the T cells; it then returns the other blood components, such as red blood cells, platelets, etc.
The T cells are then sent out to a lab, where technicians insert an anti-cancer gene into them. That new gene causes special receptors called chimeric antigen receptors to pop up on the surface of the T cells. Those receptors are like homing devices that will lock onto the matching antigen on the surface of your cancer cells.
Once the T cells are back from the lab, you will first need treatment to prepare your body to receive the new, genetically modified T cells.
What's Next for CAR-T?
As previously mentioned, the two CAR-T cell therapies approved for myeloma patients are only for those with relapsed or refractory disease, which eliminate newly diagnosed patients.
However, many SurvivorNet experts have told us they believe CAR-T cell therapy will likely be used sooner in the treatment regimen.
"My belief is that CAR-T cell therapy will likely be used sooner in the future, especially for high-risk patients and patients with certain mutations known not to derive long-term benefit from other treatments," Dr. Tareq Al Baghdadi, a medical oncologist and hematologist at St. Joe's Mercy Hospital in Ann Arbor, Mich., told us last year.
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