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The National Institute for Health and Care Excellence (NICE) has announced the approval of Kite’s CAR-T cell therapy Yescarta, for the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), who have already had two or more lines of systemic therapy.
This approval sees Yescarta, become the first personalized immunotherapy treatment to be recommended by NICE for routine use in NHS, England.
Yescarta has the potential to benefit more than 400 patients facing the aggressive forms of blood cancer, DLBCL, and PCL – for which there is currently no standard treatment after two or more systemic therapies.
The treatment will see the modification of the patient’s own T cells to program them to attach to and kill cancer cells, before being administrated in a one-off intravenous infusion.
“I am delighted that we have been able to recommend this pioneering treatment for people. The evidence from its use in the CDF and clinical trials shows it can offer an effective treatment, helping people live longer and with a better quality of life,” comments Helen Knight, director of medicines evaluation, at NICE.
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NICE’s decision follows its independent appraisal committee’s consideration of new evidence including from patients already receiving Yescarta through the Cancer Drugs Fund (CDF), and, a clinical trial.
Data presented to NICE showed that between December 2018 and October 2021, 318 people received Yescarta treatment for their aggressive lymphomas through the CDF. Of these, 45% were alive after three years, with a median overall survival of 28.5 months.
The median overall survival rate of patients receiving the best supportive care available is about 6.4 months. Therefore, evidence shows that Yescarta greatly improves life expectancy for these patients.
This NICE recommendation for routine NHS use, is an example of the benefit of these two Organisations building managed access agreements with the CDF to gain further data on promising treatments.
“Five years ago the NHS led the way in Europe by striking commercial deals for revolutionary CAR-T cancer treatment and today we have used our commercial capabilities to reach a deal that secures long-term patient access to this personalized therapy,” says John Stewart, NHS England’s Director of Specialised Commissioning and Interim Commercial Medicines Director.
Source: NICE Press Release
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