FAQ for FDA-approved CAR T-cell Therapies
Seattle Cancer Care Alliance (SCCA) is one of the first cancer centers in the nation to offer both FDA-approved CAR T-cell therapies. Tisagenlecleucel, known by the brand name Kymriah®, and axicabtagene ciloleucel (axi-cel), known by the brand name Yescarta®, are available only at certified treatment centers such as SCCA. This type of immunotherapy uses engineered T cells to harness the power of a patient’s own immune system to treat certain types of non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL).
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Patients and referring providers can speak with a specialized patient care coordinator, Monday – Friday, 8 am – 4:30 pm.
What are tisagenlecleucel and axi-cel?
These CAR T-cell therapies are different from other cancer medicines because they are made from the patient’s own white blood cells, which have been modified to recognize and attack the patient’s cancer cells.
Who is eligible for these therapies?
Axicabtagene ciloleucel (axi-cel), also known by the brand name Yescarta®, is an FDA-approved treatment for aggressive non-Hodgkin lymphoma (NHL). It is used when at least two other kinds of treatment have failed.
This therapy is available at SCCA for:
- Adult patients with confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma that has either not responded to, or relapsed after, second or greater lines of systemic therapy. Therapy must have included a CD20 antibody and an anthracycline.
- Adequate organ, cardiac and pulmonary function (must meet established criteria/measures).
Tisagenlecleucel, also known by the brand name Kymriah®, is an FDA-approved treatment for patients with acute lymphoblastic leukemia (ALL) and aggressive non-Hodgkin lymphoma (NHL).
This therapy is available at SCCA for:
- Young adults (ages 18–25) whose B-cell acute lymphoblastic leukemia (ALL) is refractory or in second or later relapse.
- Adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma or DLBCL arising from follicular lymphoma that has either not responded to, or relapsed after, second or greater lines of systemic therapy.
- Patients must have adequate organ, cardiac and pulmonary function (must meet established criteria/measures).
How are these therapies delivered?
- Because CAR T-cell therapy is made from the patient’s own white blood cells, blood will be collected by a process called “leukapheresis” (LOO-kuh-feh-REE-sis), which concentrates white blood cells.
- The patient’s blood cells are then sent to a manufacturing center to make the treatment.
- Before getting CAR T-cell therapy, the patient will usually have several days of chemotherapy to help the T cells grow.
- When CAR T-cell therapy is ready, the patient’s care team will infuse the cells through a catheter placed into a vein (intravenous infusion). The infusion usually takes less than 30 minutes.
- The patient is then monitored daily for at least seven days after the infusion.
- Patients should plan to stay close to SCCA for at least four weeks after getting treated. Our care team will help with any side effects that may occur.
- Patients may be hospitalized for side effects until they are under control and it is safe to leave the hospital.
- Patients should not drive for eight weeks following T-cell therapy.
What if CAR T-cell therapy is not appropriate for me?
These therapies are available for a certain population of cancer patients. However, patients at SCCA also have access to many different therapies, including other CAR T-cell therapies in clinical trials. Talk with our care team to learn more.
Is CAR T-cell therapy used to treat other types of cancer?
Right now, the FDA has approved CAR T-cell therapy for adult patients with certain types of lymphoma and for children and young adults with acute lymphoblastic leukemia that hasn’t responded to other forms of treatment. Clinical trials of different CAR T-cell therapies for a variety of cancers are underway at SCCA, as we are pioneers in this new form of cancer treatment.
Does insurance cover CAR T-cell therapy?
Health insurers are preparing their coverage policies for these new FDA-approved treatments. In the meantime, coverage will be reviewed on a case-by-case basis, which is typical when new therapies are first approved. SCCA will do everything we can to seek health insurance coverage for clinically-eligible patients.