NICE RECOMMENDS KITE’S TECARTUS®▼ FOR THE TREATMENT OF 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 IN ENGLAND WITHIN THE CANCER DRUGS FUND

NICE RECOMMENDS KITE’S TECARTUS®▼ FOR THE TREATMENT OF 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 IN ENGLAND WITHIN THE CANCER DRUGS FUND

London, UK - 19 January 2021 - Kite, a Gilead Company, today announced that the National Centre for Health and Care Excellence (NICE) has issued a positive recommendation on the company’s Healthcare Technology Assessment for autologous anti-CD19 transduced CD3+ cells, a chimeric antigen receptor T (CAR T) cell therapy, as a new treatment option for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

The NICE technology appraisal committee recommends making autologous anti-CD19 transduced CD3+ cells available through the Cancer Drugs Fund (CDF) for patients in England and Wales within weeks of the conditional marketing authorisation being granted by the European Medicines Agency (EMA).

Dick Sundh, Vice President, Head of Kite ACE said: “This decision by NICE represents an important step towards delivering cell therapy to UK patients living with mantle cell lymphoma, who will be among the first in the world to receive this new therapy.  Kite is the only company with two different types of cell therapies available and we will continue our strong partnership with the NHS so that eligible UK patients are able to receive treatment as soon as possible following the positive recommendation received today.”

Prof Andrew Davies, Professor of Haematological Oncology, Cancer Sciences Unit at the Faculty of Medicine, University Hospital Southampton commented: “This positive recommendation from NICE shows that cell therapies continue to broaden their role in managing lymphomas. Innovative therapies like CAR-T offer eligible patients with mantle cell lymphoma additional treatment options. The combined commitment from the NHS, regulators and industry has led to the rapid delivery of this important life sciences innovation for our patients.”

Each year around 500 people are diagnosed with mantle cell lymphoma (MCL) in the UK[i] and their 5-year relative survival from diagnosis is only 41.9%[ii]. MCL is a form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node.[iii]^,[iv] Patients with relapsed or refractory MCL after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 12.5 months.³

“This is an important day for those with MCL who may have run out of effective treatment options but now have an innovative cancer therapy that could extend their lives” says Ropinder Gill, Chief Executive of Lymphoma Action, the leading patient support charity for lymphoma in the United Kingdom. “We are delighted that all those involved have partnered effectively to quickly bring this new therapy to patients through the NHS.”