The European Medicines Agency (EMA) recently approved a new CAR T-cell therapy called KTE-X19 (also known as brexucabtagene autoleucel; brand name Tecartus) for people with mantle cell lymphoma that has come back (relapsed) or not responded (refractory) after at least two previous courses of treatment, including a targeted treatment called a BTK inhibitor (for example, ibrutinib). We are delighted that the National Institute for Health and Care Excellence (NICE) has today announced that KTE-X19 will be available on the NHS in England through the Cancer Drugs Fund. Wales and Northern Ireland usually follow NICE recommendations. Scotland has a separate appraisal process.
Mantle cell lymphoma can be an aggressive type of lymphoma. Although it usually responds well to initial treatment, it often comes back and is difficult to cure.
CAR T-cell therapy involves having your own T cells collected and genetically modified (changed) in a laboratory to help them recognise and kill lymphoma cells. The modified T cells are then given back to you, like a blood transfusion.
Two CAR T-cell therapies are already available to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B cell lymphoma. Tecartus is the first CAR T-cell treatment to be recommended for mantle cell lymphoma. Clinical trial results have been promising. However, as with other CAR T-cell therapies, Tecartus can cause serious side effects. The EMA considered that the benefits of Tecartus outweigh the risks and have granted conditional approval on the basis that it fulfils a significant unmet need for people who have limited treatment options. More information about the efficacy and safety of Tecartus in people with relapsed or refractory mantle cell lymphoma is being collected.
19 January 2021