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National Institute for Health and Care Excellence approves expanded use of Yescarta and Tecartus

National Institute for Health and Care Excellence approves expanded use of Yescarta and Tecartus
Kite – a Gilead Sciences spin out company – has announced that the National Institute for Health and Care Excellence (NICE) has recommended additional uses for their two CAR T-cell therapies.

The treatments represent options for the treatment of certain blood cancers for the Cancer Drugs Fund (CDF). Kite currently has two CAR T-cell therapies now available across the NHS covering four types of blood cancer.

Firstly, Yescartahas been recommended for treating adult patients with diffuse large B cell lymphoma (DLBCL) that relapses within 12 months of first-line treatment.

Data supporting its use is based on primary results of the pivotal phase 3 ZUMA-7 study. Herein, the primary endpoint was event-free survival (EFS). The 24-month EFS was 40.5% in the Yescarta arm and 16.3% in the standard-of-care element.

Furthermore, Kite’s second CAR T-cell therapy – Tecartus – is now available as an option for adult patients of 26 years of age and above, with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Data supporting its use was observed during the ZUMA-3 single-arm trial. In the combined phase 1/2 data set, 73% of the analysed individuals treated with Tecartus achieved overall complete remission, as determined by an independent review.

Dr Sridhar Chaganti, consultant haematologist at Queen Elizabeth Hospital, Birmingham, explained: "This decision is a pivotal moment for expanding how CAR T-cell therapy is used to treat DLBCL – until now, these therapies have been reserved for use when patients have failed traditional standard of care and had few options remaining. With today’s announcement, we will now have the option to use it earlier for some patients, potentially creating a new pathway and standard of care."

David Marks, professor of haematology and stem cell transplantation, added: “The approval of this CAR T-cell therapy for adult patients with acute lymphoblastic leukaemia represents an important change for adult all patients.”

He concluded: “In addition, certain high-risk patients who can’t achieve or maintain deep remissions, or who are unsuitable for alloHSCT, are now eligible for CAR T-cells. In ALL, patients less than 26 years old have had the option of therapy with CAR T-cells for some time and this approval now ensures patients of all ages can access the latest scientific advances.”

CAR T-cell treatments are made starting from a patient’s own white blood cells. The cells are removed through a process similar to donating blood platelets and sent to Kite’s specialised manufacturing facilities where they are engineered to target the patient’s cancer.

28th April 2023

https://www.pharmatimes.com/
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