Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017. Despite logistical challenges accompanying the manufacture of autologous T-cell therapies that limit access and contribute to the high cost of treatment, Yescarta will see strong uptake over the next decade.
Yescarta is an autologous T-cell therapy genetically engineered to express a CAR targeting cluster of differentiation (CD)19. CD19 is expressed solely on B cells; hence it is an attractive target in B-cell leukemias and B-cell lymphomas. Studies suggest a high clinical response rate of CD19 CAR-T cell-based immunotherapy in the treatment of refractory B-cell malignancies. During Yescarta therapy, the patient’s peripheral blood T lymphocytes are collected, genetically modified, and administered back in order to stimulate the patient’s own immune system to attack and kill cancer cells.
Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017. Despite logistical challenges accompanying the manufacture of autologous T-cell therapies that limit access and contribute to the high cost of treatment, Yescarta will see strong uptake over the next decade. In heavily pretreated patients, Yescarta treatment resulted in strong and durable response rates, as demonstrated in the ZUMA-1 trial. Furthermore, a future label expansion into the second-line setting based on the ongoing ZUMA-7 trial will increase Yescarta’s market potential in this indication. Yescarta will face direct competition over the forecast period from approved CAR-T therapy Kymriah (tisagenlecleucel; Novartis), as well as several late-phase competitors targeting the relapsed/refractory setting, including Celgene’s investigational CAR-T, lisocabtagene maraleucel.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Yescarta : NHL: Follicular lymphoma (FL)
15 Yescarta : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
8 Figure 1: Yescarta for follicular lymphoma – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Yescarta for follicular lymphoma
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Yescarta for follicular lymphoma
12 Figure 4: Yescarta sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
20 Figure 5: Yescarta for diffuse large B-cell lymphoma – SWOT analysis
21 Figure 6: Datamonitor Healthcare’s drug assessment summary for Yescarta in diffuse large B-cell lymphoma
22 Figure 7: Datamonitor Healthcare’s drug assessment summary for Yescarta in diffuse large B-cell lymphoma
25 Figure 8: Yescarta sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Yescarta drug profile
7 Table 2: Yescarta ongoing pivotal trial in follicular lymphoma
13 Table 3: Yescarta sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
15 Table 4: Yescarta drug profile
17 Table 5: Yescarta pivotal trial data in diffuse large B-cell lymphoma
19 Table 6: Yescarta ongoing late-phase trial in diffuse large B-cell lymphoma
26 Table 7: Yescarta sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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