Kite receives positive recommendation from SMC for CAR T therapy

pharmafile | August 10, 2021 | News story | Manufacturing and Production, Research and Development  

Kite has announced a positive recommendation from the Scottish Medicines Consortium (SMC) on the company’s Healthcare Technology Assessment for Tecartus, a chimeric antigen receptor T (CAR T) cell therapy.

The therapy has been recommended as a new treatment option for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

The recommendation follows the decision of NICE to recommend this therapy for eligible patients in England via the Cancer Drugs Fund in January 2021.

Julian Cole, Senior Director of Medical Affairs at Gilead UK and Ireland, said: “We are delighted that eligible Scottish patients with MCL will now be able to access autologous anti-CD19 transduced CD3+ cells.

“This milestone builds on the NICE approval received earlier this year and is testament to our ongoing commitment to ensure innovative therapies are available to eligible patients in difficult to treat forms of blood cancer throughout the UK.”

MCL is a form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node. Each year around 500 people are diagnosed with MCL in the UK, and according to UK data from 2004-2016, the 5-year relative survival from diagnosis is 41.9% and outcomes for patients with relapsed or refractory MCL after two or more lines of systemic therapy including a BTK inhibitor remain poor, with a median overall survival of 6 to 12.5 months.

Autologous anti CD19 transduced CD3+ cells are the active substance in Tecartus, a CAR T cell therapy and individualised method of treatment that harnesses the body’s own immune system to target cancer cells. The therapy uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature.

Ropinder Gill, Chief Executive of Lymphoma Action, the leading patient support charity for lymphoma in the United Kingdom, said: “People living with MCL who have already been through two lines of systemic therapy have limited options available to them and relatively poor outcomes. CAR T offers them another option”.

Kat Jenkins

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