The National Institute for Health and Care Excellence (NICE) has confirmed that it is recommending new CAR T-cell therapies axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel (KymriahTM) for adults with (DLBCL) who have had two or more previous courses of treatment but whose lymphoma has (come back) or was (did not respond to treatment). Axicabtagene ciloleucel is also recommended for people with relapsed or refractory primary mediastinal large B-cell lymphoma who have had two or more previous courses of treatment.
In its draft guidance, NICE did not recommend CAR T-cell therapies for DLBCL. We were among several patient representative groups and professional bodies to respond to the draft guidance and so we were pleased when NHS England negotiated a deal and are delighted that NICE has now reconsidered its decision.
The treatments will be available through the . More evidence on axicabtagene ciloleucel is being collected until February 2022 and on tisagenlecleucel until February 2023. After this, NICE will decide whether or not to recommend the treatments for routine use on the NHS and update their guidance. while long-term data is being collected
In CAR T-cell therapy, your own T cells are collected and genetically modified (changed) in a laboratory. These changes allow them to recognise and kill lymphoma cells that are otherwise not detected by your immune cells. They are then given back to you, like a blood transfusion.
The first patients to receive CAR T-cell therapy on the NHS were children with B-cell acute lymphoblastic leukaemia, who began treatment at Great Ormond Street Hospital in November. We are pleased it will now be available for some people with large B-cell lymphomas.
CAR T-cell therapy offers a potential lifeline for people with relapsed or refractory DLBCL or primary mediastinal large B‑cell lymphoma, who have limited treatment options. However, it is a very intensive treatment and you have to be fit enough to have it. It can cause serious side effects and the treatment can only be given by trained specialists in accredited hospitals with the facilities and staff to treat these side effects effectively.
At present, very few treatment centres have been accredited and the availability of CAR T-cell therapy is extremely limited. NHS England has established a panel of experts to prioritise patients for treatment while treatment centres are being set up.
Some CAR T-cell treatments are also being tested in clinical trials for DLBCL and other , although again, availability is limited.
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Graphic of CAR T-cell therapy from the National Institute for Health and Care Excellence (NICE)