Abecma™ (idecabtagene vicleucel)

Roswell Park Comprehensive Cancer Center is an authorized treatment center for Abecma™ (idecabtagene vicleucel).

What is Abecma™ (idecabtagene vicleucel)?

Abecma is an FDA-approved immunotherapy — a treatment designed to help your own immune system fight cancer. Specifically, it is a type of chimeric antigen receptor (CAR) T-cell therapy. It strengthens and multiplies your T cells, the special white blood cells in your body that have the power to destroy cancer cells.

Who is eligible?

Adults with multiple myeloma who have received at least four kinds of treatment regimens (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody) that have not worked or that have stopped working.

In addition, the Roswell Park team must determine whether the patient is well enough to undergo this type of immunotherapy.

How does Abecma work?

First, some of your T cells are collected through leukapheresis, an outpatient procedure that is very much like donating blood. The cells are sent to a laboratory, where a gene is added to strengthen their ability to find and kill cancer cells. The cells are then multiplied to become millions and millions of cancer-fighting T cells before they are sent back to Roswell Park. This process usually takes about four weeks.

Before getting those cells back, you will receive chemotherapy for three days to make room in your body for the new, stronger immune cells. Your Roswell Park team then gives the re-engineered cells back to you intravenously (through an IV). Receiving Abecma treatment is a one-time infusion.

You will be watched closely for at least seven days afterward so that the team can identify any side effects and step in quickly to manage them. For at least four weeks after receiving Abecma, you should stay near Roswell Park for continued monitoring. (Some hotels and medical hospitality houses in Buffalo offer special lodging rates for out-of-town patients who travel to Roswell Park for treatment.)

What did the clinical trial show about Abecma?

The FDA approves new treatments based on the results of clinical trials — research studies in which the treatments are given to patient volunteers for the very first time.

The clinical trial that led to FDA approval of Abecma for multiple myeloma showed that of 100 participants, 72% (72 patients) experienced overall response, a meaningful decrease in the signs of myeloma. In addition, 29% (29) patients in the trial experienced complete response or better, indicating that there was no detectable evidence of cancer in the body and all signs of myeloma disappeared.

What are the side effects of Abecma?

The most common side effect of CAR T-cell immunotherapy, cytokine release syndrome (CRS), occurs when there is a very strong response by the immune system. Patients may experience fever, difficulty breathing, dizziness, nausea, headache, fast heartbeat, low blood pressure and fatigue. Although the symptoms are mild in most patients, in some cases, CRS may be serious and even life-threatening.

Abecma can increase the risk of life-threatening infections and you will need to tell your doctor right away if you develop fever, chills an any other signs of infection.

Abecma can lower the number of your other blood cell types (red blood cells, white blood cells or platelets) and make you feel weak, tired, and increase risk for infection and bleeding. Your blood cell counts will be checked after treatment and you will need to report any fever, fatigue, bruising and bleeding to you doctor.

Abecma can cause neurologic side effects like difficulties focusing on task or confusion.

Having Abecma in your blood can produce a false positive result in some commercial tests for human immunodeficiency virus (HIV).

In most cases, serious side effects occur within four weeks after treatment. You will need to stay close to Roswell Park for several weeks so you can be watched closely for signs of these side effects and treated immediately.

What sets Roswell Park apart?

• Patients who receive CAR T-cell therapy are treated at our Transplant and Cellular Therapy (TCT) Center where members of the medical team have significant experience in recognizing and managing the side effects of immunotherapies. Our team includes national leaders who helped develop the guidelines for managing the side effects of cellular therapies.
• The Foundation for the Accreditation of Cellular Therapy (FACT) has accredited Roswell Park as both an adoptive cellular therapy program and a bone marrow transplant (BMT) program. This indicates that Roswell Park adheres to strict standards and works constantly to achieve the best patient outcomes.
• Every patient who comes here for cellular therapy is monitored by a team of experts. The team meets every week, monitoring the patient’s status to ensure the best possible care.

Will my insurance cover Abecma?

Abecma is covered by many major health plans, including New York State Medicaid. Please contact your insurer directly to find out whether or not it is included in your specific plan.

What if I’m not eligible for Abecma?

Our experts can identify all the options available to you, including any FDA-approved therapies and new treatments offered through clinical trials. Roswell Park is one of very few centers in the United States equipped to offer clinical trials of a full range of immunotherapies, including many that were developed right here. We are home to one of the largest phase I clinical trials programs in New York State.