Abecma (idecabtagene vicleucel; ide-cel) is used to treat patients with relapsed or refractory multiple myeloma after two or more prior lines of treatment or therapy.

The approval comes just a few weeks after the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted in support of both Abecma and Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) for use in multiple myeloma patients who experienced relapse earlier rather than waiting until after they’ve undergone four or more prior lines of treatment or therapy.

Dr. S. Vincent Rajkumar is a Mayo Clinic medical oncologist specializing in multiple myeloma.

Dr. Rajkumar says, “There are many good treatments for earlier stages of relapsed myeloma, and they have a long track record of efficacy and safety. We need more data on the sequencing of CAR T vs. established treatments for relapsed disease in terms of overall survival, cost, and toxicity,” Dr. Rajkumar said.

The two CAR T-cell therapy treatments drew initial concern because, during clinical trials, some patients experienced an increased rate of early deaths. It was found that approximately 8% of trial patients died after Carvykti or Abecma CAR T-cell Therapy treatments, which is more than those treated with standard forms of therapy, according to Reuters.

However, regulators felt the benefits of these CAR T-cell therapies outweighed their risks, noting that they provided a 59% reduction in multiple myeloma disease progression.

“The utilization of a ‘one and done infusion’ with cilta-cel and ide-cel in earlier lines of therapy offers patients a chance for deep and durable responses, ultimately favoring the benefit-risk profile of both CAR T products earlier in the treatment course,” Dr. Doris Hansen at Moffitt Cancer Center tells SurvivorNet.

Dr. Hansen adds that patients who experienced early deaths during clinical trials were more related to disease progression because they “were not able to receive the products in time.” Hence, their deaths were more tied to disease pr

WATCH: The Value of CAR T-Cell Therapy for Patients.

It should be noted that as of this publication, the FDA has not approved Carvykti.

Carvykti (which has the molecular name cilta-cel) was approved by the FDA in 2022 to treat adults diagnosed with relapsed or refractory multiple myeloma who already received four or more prior lines of therapy, which includes proteasome inhibitor (blocks the protein complex proteasome to help the body fight cancer), an immunomodulatory agent (stimulates the immune system to fight cancer) and anti-CD38 monoclonal antibody (blocks the CD38 protein on cancer cells to help the immune system fight cancer).

Abemca (also called ide-cel) received the same FDA approval for the treatment of adults with relapsed or refractory multiple myeloma who already received four or more prior lines of therapy in 2021.

After the first treatment, many people with multiple myeloma have a long period of remission. It’s common to go three years or longer without your symptoms returning. But in time, the cancer can come back or relapse.

“Relapse, unfortunately, is inevitable for patients with myeloma,” Dr. Sumit Madan tells SurvivorNet. He’s a multiple myeloma specialist at Banner MD Anderson Cancer Center in Arizona. If or when that happens, your doctor will plan the next phase of your treatment.

Multiple Myeloma Relapse

When your multiple myeloma comes back within about a year, your disease is generally classified as ‘high risk.’

When multiple myeloma returns after treatment, “It usually means that there were residual cells, even in very small numbers. They were either resistant to the treatment from the start, or they acquired resistance as the treatment was growing,” Dr. Kenneth Anderson, Director of Dana Farber Cancer Institute’s Multiple Myeloma Center, explains to SurvivorNet.

In other words, not every myeloma cell in your body is precisely the same. Some start with a set of mutations that can give them resistance to treatments and make them more likely to relapse, whereas others develop mutations as a result of treatment.

The Signs of a Multiple Myeloma Relapse

• Increased levels of monoclonal antibodies: Myeloma cells are cancerous plasma cells in the bone marrow that overgrow and produce abnormal proteins. These abnormal proteins are released in the blood and can be detected by physicians. When the levels of these increase substantially, that can be a sign that multiple myeloma has relapsed.
• Increase in plasma cells in the bone marrow: oncologists can use magnetic imaging, like MRI or PET scans, to see if there are a greater than normal level of plasma cells in the bone marrow, typical of overly dividing myeloma cells.
• Bone fractures and lesions: Myeloma cells activate the cells that break down bones and deactivate the cells that build up bones, which can result in fractures or small holes in bones. Oncologists can use X-rays or CT scans to detect bone damage indicative of relapse.

WATCH: Coping With Relapse.

What’s the Effectiveness of CAR T-cell Therapy?

Your immune system comes equipped with an army of white blood cells, called T cells, that normally protect it from infections and cancer. But sometimes, these cells miss their target. “The cells that help fight cancer unfortunately don’t recognize their own cancer anymore,” Dr. Julie Vose, chief of hematology/oncology at the University of Nebraska Medical Center, tells SurvivorNet. CAR T-cell therapy “helps to wake up those cells to be able to fight cancer.”

The entire process involved in getting CAR T-cell therapy can take a few weeks. It starts by drawing your blood and separating out the T cells.

Then, using a virus modified to be harmless, the T cells are genetically engineered to produce proteins called chimeric antigen receptors (CARs) on their surface. These receptors will enable the cells to recognize and attach to a matching protein, called an antigen, on the tumor cell just as a key fits into a lock. The process primes the T cell to “recognize the cancer and to fight it,” Dr. Vose says.

Next, the modified cells are multiplied into the millions in a laboratory. You’ll need a lot of them to fight your cancer.

The CAR T cells are specific to your cancer. For example, some types of lymphoma cells have the antigen CD19 on their surface. CAR T-cell therapies for those cancer types only target the CD19 antigen.

A few days before the infusion, you’ll get chemotherapy to clear out some of your immune cells and prime your body to receive the CAR T cells. This will help the CAR T cells work better. Finally, the modified T cells will be infused back into your body to hunt down the cancer.

CAR T-cell therapy has shown a response rate as high as roughly 80 percent in some blood cancers after other treatments have failed. In lymphoma, more than 54% of people who took the FDA-approved CAR T-cell therapy axicabtagene ciloleucel (Yescarta) and 40% of those who took tisagenlecleucel (Kymriah) achieved a complete response, meaning they no longer had any sign of cancer in their body. With Yescarta, 40% of people were still in remission an average of 15 months after their treatment.

Those who get CAR T-cell therapy have already been through at least two other treatments—usually rituximab (Rituxan) plus chemotherapy and high-dose chemotherapy. “Some of these patients had three, four, or five prior lines of therapy, and we were able to save their lives,” Dr. Stephen Schuster, director of the Abramson Cancer Center’s lymphoma program, tells SurvivorNet.

WATCH: Why CAR T-Cell Therapy is an Exciting Treatment to Explore.

What Are the Side Effects of CAR T-Cell Therapy

CAR T-cell therapy differs from chemotherapy cancer treatment because it doesn’t cause hair loss and nausea. However, it still has side effects. When CAR T-cells multiply in the body, they trigger the release of inflammatory chemicals called cytokines. This can lead to a condition known as cytokine release syndrome (CRS), with symptoms such as high fevers, weakness, chills, and low blood pressure. Another possible side effect of CAR T-cell therapy is brain changes that can lead to confusion and a lack of awareness.

WATCH: Known CAR T-Cell Therapy Side Effects

When side effects do occur, the mildest one is fatigue.

“That’s very normal, and it usually resolves in the first month,” says hematologist Dr. Nina Shah.

A more serious side effect of CAR T-cell therapy is called cytokine release syndrome (CRS). CRS occurs when the CAR-T cell therapy causes a significant, rapid release of cytokinessmall proteins that are part of the immune system into the circulation. That release can cause a variety of reactions. The flu-like symptoms of CRS can include headache, fever, chills, scratchy throat, nausea, vomiting, diarrhea, muscle or joint pain, and lack of energy. In addition, CRS can cause shortness of breath, low blood pressure, and fast heart rate. Most people who develop CRS will have mild to moderate symptoms, but sometimes, CRS can be severe and even life-threatening.

If CAR T-Cell therapy is a treatment option, you should discuss all possible side effects with your doctor.

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