FDA's Tecartus Approval Offers 'More Specific Answer' to Patients with Relapsed Acute Lymphoblastic Leukemia

Earlier this month, the Food and Drug Administration (FDA) approved Tecartus (brexucabtagene autoleucel) for the treatment of patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) – marking the first CAR-T cell therapy for this patient population.

CAR-T cell therapy is a type of blood cancer treatment where patients’ blood is drawn and then engineered so that the T cells can better recognize and attack cancer. In order to be successful, patients must not do anything that can damage their T cells, such as go on steroids or drugs that can cause T cells to underperform.

Once cells are taken out, they must be turned into a successful CAR-T cell product, which takes about two weeks, and is going to be successful about 90% of the time, explained Dr. Bijal D. Shah, associate member in the department of Malignant Hematology at the Moffitt Cancer Center.

“I do tell patients that if their white blood cell counts are very low or they are receiving medications that affect T cells or if they just have a lot of inflammation, I warn patients that their T cells might not successfully manufacture, and that’s particularly important when we talk about moving from a clinical trial into the real world, because we’re going to be much more restricted in terms of what is going to be an effective product,” Shah said in an interview with CURE®.

Shah said that Tecartus is “not a perfect treatment,” but can be extremely beneficial to eligible patients. This was the case with Branden*, a 29-year-old who was diagnosed with ALL as a teenager and underwent years of treatment – including a bone marrow transplant – and faced two relapses.

After Branden started getting painful residual cancerous spots on his wrist, the Florida resident thought that he was out of options, when his treatment team approached him about receiving Tecartus, the experimental CAR-T cell therapy.

“It got to the point where the only other options were another bone marrow transplant or to join this research trial,” Branden said in an interview with CURE®. “A bone marrow transplant is a good option, but it takes a lot out of you. So, when I had another option in front of me that seemed like it would be less taxing, it seemed like a more specific answer for what I had because it was mainly to help with residual disease.”

At first, Branden said that he was a bit nervous about enrolling in a clinical trial, but he maintained a positive attitude throughout his entire cancer journey, and this was no different. In 2018, he received a CAR-T cell infusion. He stayed in the hospital for about two weeks and said that he did not experience any major side effects.

Since then, he has been in remission.

“I’ve felt good ever since. I haven’t had any (cancer) pop back up,” he said.

While Branden said that joining a clinical trial was the right decision for him, he said that each patient should consider if it – or CAR-T cell therapy in general – is right for them in their specific circumstances.

“I feel like this therapy is something (others) should think about, especially for residual disease. I can’t imagine going through another bone marrow transplant for something that isn’t a full-fledged relapse,” he said.

While Branden was lucky to report no side effects, there are some that patients should be aware of. The main ones are neurotoxicity and cytokine release syndrome, where the body releases too many inflammatory cells.

“Cytokine release syndrome, for the most part, has gotten relatively easy to manage. It’s not 100%; there are still some tough cases that we see, but for the most part, we’re going to see it, we’re going to intervene early,” Shah said. “When we talk about neurologic toxicity, what we’re really seeing clinically is a process that begins with difficulty finding words then progresses to some degree of confusion.”

If patients who receive Tecartus experience this, they should contact their care team immediately. But even after considering the side effects, treatment with Tecartus might be the right option for many patients with ALL.

“If the person is in a similar situation (to me), they’ve tried other things or maybe it’s not a whole lot of disease coming back, I feel like CAR-T cell therapy is something to think about,” Branden said.

*Surname omitted.

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