FDA-approved CAR T cell therapies
Currently, seven CAR T cell therapies have been approved by the Food and Drug Administration (FDA) for use in treating various cancer types in adults and children. While CAR T therapy has been proven to be an effective treatment for some blood cancers, it is not currently recommended for all cancers. Penn Medicine researchers are conducting clinical trials for additional gene and cell immunotherapies that may be available in the future to treat many conditions. If you have a cancer type that can be treated with CAR T therapy, your doctor will discuss the appropriate treatment options with you. We offer several T cell therapy options to patients who might benefit.
Kymriah® (tisagenlecleucel) is an immunotherapy treatment for certain types of lymphoma and leukemia. This genetically modified T cell therapy targets CD19, a protein found on the surface of certain cancer cells. The development of Kymriah began in 2010 with trials at Penn Medicine for patients with advanced chronic lymphocytic leukemia (CLL) in adults. In 2012, trials expanded to pediatric patients with acute lymphoblastic leukemia (ALL) in collaboration with Children’s Hospital of Philadelphia (CHOP). Kymriah made history in 2017 as the first FDA-approved CAR T cell therapy for certain pediatric and young adult patients with ALL. It was followed by an approval for patients with certain lymphoma types in 2018. It is currently FDA-approved to treat patients with:
- Diffuse large B cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
- Acute Lymphoblastic Leukemia (ALL)
Breyanzi® (lisocabtagene maraleucel) is a genetically modified T cell treatment designed to target the CD19 protein present on cancer cells in certain lymphomas. Breyanzi was approved by the FDA in 2021 for treating certain adults with relapsed or refractory large B-cell lymphoma. In 2024, it was additionally approved for adult patients with relapsed or refractory small lymphocytic lymphoma (SLL) and chronic lymphocytic leukemia (CLL). Patients who have these conditions may be recommended for Breyanzi if: their cancer has not responded to initial chemoimmunotherapy or their cancer relapses within 12 months of treatment; their cancer comes back or doesn’t respond after trying two or more different treatments; their age or other health problems make them ineligible for hematopoietic stem cell transplantation (HSCT) and their cancer has relapsed after chemoimmunotherapy.
Breyanzi is currently approved to treat adult patients with:
- Large B-cell lymphoma (LBCL)
- Diffuse large B-cell lymphoma (DLBCL)
- Chronic lymhocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma (FL) grade 3B
Yescarta ® (axicabtagene ciloleucel) is a breakthrough T cell treatment for lymphoma. This genetically modified T cell therapy targets the CD19 protein found on certain cancer cells. Yescarta was FDA-approved in 2017 to treat adult patients with large B-cell lymphoma that doesn’t don’t respond to initial chemoimmunotherapy or relapses within 12 months of the first treatment, and adult patients with relapsed or refractory large B-cell lymphoma after trying two or more different systemic therapies. In 2022, Yescarta was additionally approved for adult patients with relapsed or refractory follicular lymphoma after trying two or more systemic therapies. Yescarta is currently FDA-approved to treat patients with certain types of:
- Diffuse large B cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
Tecartus® (brexucabtagene autoleucel) is a CD19-directed genetically modified T cell therapy for certain types of lymphoma. When it was FDA-approved in 2020, it marked a significant breakthrough as the first cell-based gene therapy approved for mantle cell lymphoma (MCL). Tecartus was initially approved for adult patients with relapsed or refractory MCL. In 2021, Tecartus was additionally approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Tecartus is currently FDA-approved to treat patients with certain types of:
- Mantle cell lymphoma (MCL)
- Acute Lymphoblastic Leukemia (ALL)
Abecma ® (idecabtagene vicleucel) is a cell-based gene therapy. In 2021, Abecma became the first cell-based gene therapy to be FDA-approved for treating multiple myeloma. It is recommended for adult patients whose myeloma has returned or hasn’t responded after trying two or more other treatment types. Before Abecma, treatments for multiple myeloma were limited to chemotherapy and corticosteroids.
Carvykti® (ciltacabtagene autoleucel) is a treatment that targets a protein called B-cell maturation antigen (BCMA) with genetically modified T cells. In 2022, it became the first and only FDA-approved BCMA-targeted therapy for multiple myeloma patients who have received at least one prior line of therapy. The treatment, was later approved for adult multiple myeloma patients whose myeloma has relapsed or has not responded after trying previous treatments, marking a significant advancement in options for these patients.
Tecelra® (afamitresgene autoleucel) is a gene therapy treatment for synovial sarcoma. Approved by the FDA in 2024, it is the first CAR T treatment approved for use on a solid tumor and the first new treatment option for synovial sarcoma in over a decade. The treatment is approved for adult patients with synovial sarcoma that cannot be removed through surgery or has spread from another area of the body, have received chemotherapy previously, and have a qualifying HLA type and tumor expression. According to the Cancer Research Institute, it has shown remarkable efficacy in clinical trials targeting the MAGE-A4 protein on cancer cells, giving the immune system greater ability to recognize and eliminate them.