Following a priority review, Health Canada has approved tisagenlecleucel (Kymriah) for the treatment of relapsed/refractory paediatric and young adult (3-25 years of age) B-cell acute lymphoblastic leukaemia and adult relapsed/refractory diffuse large-B cell lymphoma (DLBCL). This is the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.
CAR-T therapy involves extracting T cells from a patient, which are then genetically engineered to produce receptors on their surface called chimeric antigen receptors (CARs). The CARs allows T cells to recognise and kill cancer cells that contain the specific antigen on its surface. Early studies have been successful and there is optimism that this treatment will be widely used in several lymphoma types in future.
The positive decision by Health Canada follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP) for use of Kymriah in Europe earlier in July, as well as the news last week that NHS England had reached an agreement to reimburse Kymriah on the NHS.