Axicabtagene ciloleucel for treating relapsed or refractory follicular lymphoma
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2 Information about axicabtagene ciloleucel
Anticipated marketing authorisation indication
2.1 Axicabtagene ciloleucel (Yescarta, Kite) is indicated 'for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy'. Axicabtagene ciloleucel has not yet been granted a marketing authorisation from the Medicines and Heathcare products Regulatory Agency (MHRA). On 22 April 2022 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for axicabtagene ciloleucel, intended for treating relapsed or refractory follicular lymphoma after 3 or more lines of systemic therapy.
Dosage in the marketing authorisation
2.2 The dosage schedule will be available in the summary of product characteristics for axicabtagene ciloleucel.
Price
2.3 The list price for axicabtagene ciloleucel is £280,451. The company has a commercial arrangement. This makes axicabtagene ciloleucel available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.
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