Car T Cell Therapy is a type of cancer treatment that involves genetic modifications of T cells. This treatment has been in existence for a while and has been used to treat different types of cancer, including blood cancer. However, there have been concerns about the safety of this treatment, and many people have been wondering if it is FDA approved.
What is Car T Cell Therapy?
Car T Cell Therapy is a type of cancer treatment that is designed to enhance the immune system’s fight against cancerous cells. It involves the collection of T cells from a patient’s body and then modifying them using the chimeric antigen receptor (CAR) method. The CAR method involves the genetic modification of T cells in the lab, adding a gene that targets cancer cells. The modified T cells are then infused back into the patient’s bloodstream, where they multiply and attack the cancer cells. This is a targeted and personalized approach to cancer treatment, and it has been successful in many cases.
How does Car T Cell Therapy work?
The Car T Cell Therapy process involves these four stages:
- T cell collection: The T cells are collected from the patient’s bloodstream using a process called leukapheresis. The collected cells are sent to a lab for genetic modification.
- Genetic modification: The T cells are modified in the lab using the CAR gene, which targets cancer cells. The modified cells are then multiplied in the lab to produce large quantities.
- Infusion: The modified cells are infused back into the patient’s bloodstream. The cells target and attack the cancer cells in the patient’s body. This is done in a hospital setting, and patients are closely monitored after infusion.
- Observation: Patients undergo regular follow-up appointments to monitor their response to the treatment and any side effects.
Is Car T Cell Therapy FDA approved?
Yes, Car T Cell Therapy is FDA approved, but only for certain types of blood cancer. The first Car T Cell Therapy treatment to be approved by the FDA was for the treatment of children and young adults with acute lymphoblastic leukemia (ALL) in 2017. The approval was based on clinical trials that showed positive results. Since then, the FDA has approved Car T Cell Therapy for the treatment of adults with certain types of non-Hodgkin lymphoma.
What are the FDA-approved Car T Cell Therapy drugs?
As of 2021, the FDA has approved two Car T Cell Therapy drugs:
- Kymriah (tisagenlecleucel): Approved for the treatment of pediatric and young adult ALL, and certain types of non-Hodgkin lymphoma.
- Yescarta (axicabtagene ciloleucel): Approved for the treatment of certain types of non-Hodgkin lymphoma in adults.
What types of cancer can Car T Cell Therapy be used for?
Currently, Car T Cell Therapy is only FDA approved for the treatment of certain types of blood cancer, including B-cell ALL and certain types of non-Hodgkin lymphoma in adults. However, clinical trials are ongoing for the treatment of other types of cancer, including solid tumors.
Is Car T Cell Therapy safe?
Car T Cell Therapy is generally considered safe and well-tolerated, but there are risks involved. The most common side effects include fever, fatigue, headache, and muscle pain. Patients may also experience more serious side effects, such as neurologic toxicities and cytokine release syndrome (CRS). This is why Car T Cell Therapy is only available in specialized centers with trained healthcare providers.
What are the benefits of Car T Cell Therapy?
Car T Cell Therapy has several benefits, including:
- Potentially curative: Car T Cell Therapy has shown promising results in many clinical trials, with some patients achieving long-term remission.
- Personalized: Each patient’s T cells are genetically modified and infused back into their own body, making it a personalized treatment approach.
- Minimal long-term side effects: Unlike chemotherapy and radiation, Car T Cell Therapy does not damage healthy cells in the body, which leads to minimal long-term side effects.
Car T Cell Therapy is a promising cancer treatment that has shown positive results in clinical trials. While it is only FDA approved for certain types of blood cancer, ongoing research and clinical trials are exploring its potential for other types of cancer. If you or someone you know has been diagnosed with cancer, it is important to discuss all available treatment options with a healthcare professional.
Common Questions and Answers
Is Car T Cell Therapy expensive?
Yes, Car T Cell Therapy is an expensive treatment, with costs estimated to be more than $475,000 per patient. However, some insurance companies and financial assistance programs may cover some or all of the costs.
Can Car T Cell Therapy cause long-term side effects?
While Car T Cell Therapy does not cause long-term damage to healthy cells, some patients may experience long-term side effects, such as cognitive impairment, vision changes, and autoimmune diseases. Further research is necessary to fully understand the long-term effects of this treatment.
Can Car T Cell Therapy be combined with other treatments?
Yes, Car T Cell Therapy can be combined with other cancer treatments, such as chemotherapy or radiation therapy. However, the timing and specific combination of treatments should be determined by a healthcare professional.
Is Car T Cell Therapy available globally?
Car T Cell Therapy is currently only available in a limited number of countries, including the United States, Canada, and some European countries. However, ongoing research may lead to its availability in other countries in the future.
- U.S. Food and Drug Administration. (2021). Approved Cellular and Gene Therapy Products. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
- NIH National Cancer Institute. (2021). CAR T-cell therapy. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
- American Cancer Society. (2021). CAR T-cell therapy for cancer. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell-therapy.html