Treating cancer can be challenging. While there are many different potential therapeutic options designed for people with cancer, these treatments are not always effective. Chimeric antigen receptor (CAR) T cell therapy, also known as CAR-T cell therapy or CAR-T, holds the potential to help patients whose cancer has not responded to other treatments.
The Memorial Sloan Kettering Cancer Center explains that CAR-T cell therapy:
involves removing immune cells called T cells from the blood and introducing a new gene into those cells that enables them to recognize the cancer. After the gene is inserted, the T cells are infused back into the bloodstream, where they multiply and initiate a variety of immune responses aimed at attacking the cancer cells.
Over the past six or seven years, multiple CAR-T cell therapies, including Kymriah (developed by Novartis) and Yescarta (developed by Gilead), became FDA-approved. These therapies are typically used to treat blood cancers including, but not limited to, diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma, mantle cell lymphoma, adult leukemia, and multiple myeloma. Tests show that CAR-T cell therapy contributes to long-lasting, durable responses. CAR-T cell therapy does come with a risk of cytokine release syndrome, which means that the immune system responds more aggressively to treatment than it should. Cytokine release syndrome can cause potentially life-threatening symptoms, so it is important to see your healthcare provider right away if you are on CAR-T cell therapy and experience lingering flu-like symptoms.
A Risk of Secondary Malignancies with CAR-T Cell Therapy
Although CAR-T cell therapy has shown promise in many cancers, there are potential issues associated with this treatment. Jonathan Gardner reports in Biopharma Dive that the FDA is currently investigating whether CAR-T could increase the risk of developing secondary malignancies (i.e. another blood cancer). The risk of secondary malignancies from cancer treatments – including those beyond CAR-T – has already been established. However, the FDA received an unspecified number of reports from clinical studies and patient use about the development of CAR-positive lymphoma following this treatment.
Spokespeople from Bristol Myers Squibb and Novartis, as well as Dr. Stephen Grupp from the Children’s Hospital of Philadelphia (CHOP), have all shared that they have not seen any cases of CAR-positive lymphoma in patients treated with CAR-T cell therapies like Kymriah, Abecma, or Breyanzi.
The FDA currently believes that the benefits of CAR-T outweight the risks, so they are not issuing any other guidelines at this point in time. However, the FDA is planning on exploring whether regulatory action is needed, and will hold an advisory committee to review whether Abecma should be moved into earlier treatment.