First CAR-T therapies approved by European regulators

The first chimeric antigen receptor T-cell therapies (CAR-T), named Kymriah and Yescarta, have been approved by European regulators, enabling patients to access CAR-T therapies for the first time.

Kymriah (tisagenlecleucel) has been approved for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. Kymriah is also approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systematic therapy.

Yescarta (axicabtagene ciloleucel) has also been approved for DLBCL and additionally approved for primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.

The CAR-T therapies represent a brand new approach to fighting cancer, since the therapy involves extraction of infection-fighting cells from a patient. These cells are then genetically engineered to recognise cancer cells and infused back.

The new therapies are being assessed by the National Institute for Health and Care Excellence (NICE) for use on the National Health Service (NHS) in England. However, NICE has recently released a draft decision which rejects funding for Yescarta as the price is too high for it to be considered cost-effective. A final decision on both drugs is expected by late 2018.

To read more about the new CAR-T therapies, please click here.