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Today, the National Institute for Health and Care Excellence (NICE) has approved the use of axicabtagene ciloleucel (brand name Yescarta) to be funded for use on the NHS in England. It will be available for patients with diffuse large B-cell lymphoma (DLBCL) and primary mestinal B-cell lymphoma (PMBL), after they have tried two other systemic therapies. Yescarta is a brand of chimeric antigen receptor (CAR) T-cell therapy, and is manufactured by Kite Pharma.
Yescarta will be funded through the Cancer Drugs Fund (CDF), as NICE decided the evidence that Yescarta was better than other available drugs was not yet strong enough. Clinical trials assess drugs by determining if they have any benefit over drugs currently used for the particular disease; the current drug chosen for comparison is called the comparator. It was difficult to find a comparator for Yescarta because there are few other options available to these patients who have already tried two therapies; they have exhausted most options already. The CDF allows the NHS to get a funding agreement whilst more data on the effectiveness of the drug is gathered, and so patients can access the drug immediately while this happens.
Lymphoma is a type of cancer involving the lymphatic system, which is system of vessels that run through your body in a similar way to the veins and arteries of your blood. Lymph (the liquid in the lymphatic system) carries cells of the immune system around the body and there are certain areas where immune cells can gather and complete their development; these are called lymph nodes. Lymphoma occurs when abnormal immune cells collect in lymph nodes (sometime other areas too like the liver, spleen or bones), stopping the lymph nodes from working properly.
DLBCL is a type of lymphoma where abnormally large B-cells accumulate, stopping the lymph node for working normally. PMBL is a rare type of DLBCL that affects mainly young adults. In this type of lymphoma, the B-cells start accumulating in the chest under the breastbone or sternum; one symptom is can fluid on the lungs, caused by the pressure of the cells gathering in the wrong place. More information on the types of lymphoma affected by this announcement can be found here.
CAR-T therapy, also called adoptive cell therapy, is a type of immunotherapy, meaning parts of the immune system are used as a treatment. Immunotherapy usually uses parts of the immune system made in other animals or in a laboratory, such as antibodies. CAR-T cell therapy is brand new and innovative, involving harvesting of the patient’s own immune cells from their body to be used in the treatment. The cells taken are then edited to be more effective at fighting the cancerous cells, then returned to the patient’s blood to start fighting the cells. There can be some severe side effects, but the treatment is approved here for use where lymphoma patients have tried other therapies, which may have less severe side effects, but they have not worked.
Our Patient Advocacy Director, Zack Pemberton Whiteley, said ““The potential of CAR-T therapy is promising, with the potential to cure lymphoma patients who have exhausted most alternative treatments. We are glad that NICE has chosen to enter Yescarta into the cancer drugs fund so patients are able to access this important new treatment as soon as possible.”
The first brand of CAR-T therapy to be approved was Tisageneleucel-T (Kymriah, manufactured by Novartis), which NICE and NHS England confirmed earlier this year. You can see our response to the decision on Kymriah here.