Yescarta Approved in Scotland as First Second-Line CAR-T Therapy for DLBCL
Key Insights
The Scottish Medicines Consortium (SMC) has approved Yescarta (axi-cel) for adult patients with diffuse large B-cell lymphoma (search) (DLBCL (search)) and high-grade B-cell lymphoma (search) (HGBL).
This marks the first time a CAR T-cell therapy has been accepted for second-line treatment in Scotland, offering a new option for patients who have relapsed or are refractory to initial treatments.
The approval was based on clinical trials, ZUMA-7 and ALYCANTE, demonstrating axi-cel's superiority over standard treatments in relapsed/refractory DLBCL (search), with improved survival rates and progression-free survival.
The Scottish Medicines Consortium (SMC) has approved Kite (search)’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), for treating adult patients with diffuse large B-cell lymphoma (search) (DLBCL (search)) and high-grade B-cell lymphoma (search) (HGBL). This decision marks a significant advancement in the treatment landscape for aggressive B-cell lymphomas in Scotland. It is the first CAR T-cell therapy approved for second-line treatment in the country.
DLBCL (search), an aggressive form of non-Hodgkin lymphoma, affects approximately 450 new patients in Scotland each year. While 50 to 60% of patients respond to initial treatment, a significant portion experience relapse or have refractory disease, necessitating alternative treatment options. The approval of axicabtagene ciloleucel offers a crucial new treatment option for these patients.
Josh Hill, Scottish Policy Officer at Blood Cancer UK, stated, “Blood cancer survival rates in the UK lag behind countries of similar wealth and health, and the blood cancer community deserves better. It’s great that people with DLBCL (search) in Scotland now have access to the drug axi-cel on the NHS in this setting, where it is already available in England and Wales.” He further added, “CAR T therapies offer hope to people who are often living with the most aggressive forms of blood cancer, and having earlier access to this innovative drug across the UK is an important step in improving outcomes for patients.”
Clinical Trial Data
The SMC's decision was supported by data from two pivotal clinical trials, ZUMA-7 and ALYCANTE. These trials demonstrated axicabtagene ciloleucel's superiority over standard treatments in patients with relapsed or refractory DLBCL (search). The ZUMA-7 study, in particular, highlighted a 24-month event-free survival rate of 41% for patients treated with axicabtagene ciloleucel, compared to only 16% with standard care.
Peter Wickersham, Vice President and General Manager, Gilead Sciences UK & Ireland, expressed pride in the approval: “From the first clinical trials, we have been committed to ensuring equitable access to our cell therapies. We are proud to now offer the first cell therapy treatment for patients in a second-line setting in Scotland, including both those eligible and ineligible for stem cell transplant. This news marks a significant step forward for the blood cancer community.”
The availability of axicabtagene ciloleucel in Scotland is expected to improve outcomes for patients with relapsed or refractory DLBCL (search), providing a potentially curative treatment option where limited alternatives exist.