Kymriah EMA Approval

Kymriah EMA Approval

Kymriah (tisagenlecleucel) is a genetically modified autologous T-cell immunotherapy product for the treatment of certain types of cancer. It was initially approved by the U.S. Food and Drug Administration (FDA) in 2017 and later by the European Medicines Agency (EMA) in 2018.

Kymriah EMA Approval

– In August 2018, the EMA approved Kymriah for the treatment of:

1) Pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse after transplant or in second or later relapse.

2) Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

– Kymriah was the first CAR-T (Chimeric Antigen Receptor T-cell) therapy approved in Europe.

– The approval was based on clinical trials that demonstrated high remission rates in patients who had failed previous treatments.

– Kymriah works by modifying a patient’s own T-cells (a type of immune cell) to express a chimeric antigen receptor (CAR) that targets and kills cancer cells expressing a specific antigen called CD19.

– The EMA approval made this innovative gene therapy available to eligible patients across the European Union, providing a new treatment option for those with limited alternatives.

In summary, the EMA’s approval of Kymriah in 2018 marked a significant milestone in bringing this pioneering CAR-T cell therapy to patients in Europe with certain types of difficult-to-treat blood cancers.