2018: First CAR T cell therapy approved in the US for adult patients with DLBCL and amongst the first approved in Europe

Nominated by: Kite (a Gilead Company)   

Organisations in nomination: Kite (a Gilead Company)

Non-Hodgkin lymphoma (NHL) can occur at any age, and accounts for an estimated 510,000 new cases and 248,724 deaths worldwide every year. Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive form of NHL. DLBCL patients for whom two lines of therapy have failed face limited treatments options and a poor prognosis.

Chimeric Antigen Receptor (CAR) T cell therapy is an individualised treatment that uses the patient’s own immune system. After the patient’s ‘T cells’ are extracted from their blood, they are processed so that when they are infused back into the patient they can recognise and more effectively target the patient’s cancer cells. As such, CAR T therapy is tailor made for each patient and intended to be administered as a single one-off infusion.

Kite’s CAR T cell therapy received priority review status by the FDA in May 2017 and became the first CAR T therapy approved by the FDA for adults with advanced large B-cell lymphoma in October 2017. It was subsequently approved by the European Commission in August 2018.

Manufacture of CAR T therapeutics is growing in Europe, with Kite’s investment in an advanced manufacturing facility near Amsterdam indicating the complex and specialised development and supply process behind such novel therapeutic interventions.

Given its potential, CAR T cell therapy has been referred to as a “game changer in cancer treatment” and there is currently a rapidly expanding pipeline of research which aims to expand the use of CAR T across different types of cancers.

i American Cancer Society, Key Statistics for Non-Hodgkin Lymphoma
ii Adalberto Miranda‑Filho et al, Global patterns and trends in the incidence of non-Hodgkin lymphoma
iii Almåsbak H, Aarvak T, Vemuri MC. CAR T Cell Therapy: A Game Changer in Cancer Treatment. J Immunol Res. 2016;2016:5474602. doi:10.1155/2016/5474602
iv Jia Xin Yu et al. The global pipeline of cell therapies for cancer, Nature Reviews Drug Discovery. 2019;18(11):821‑822.
v Firor AE, Jares A, Ma Y. From humble beginnings to success in the clinic: Chimeric antigen receptor-modified T-cells and implications for immunotherapy. Exp Biol Med (Maywood). 2015;240(8):1087–1098. doi:10.1177/1535370215584936


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