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Yescarta

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    Report

  • 19 Pages
  • January 2019
  • Region: Global
  • Citeline
  • ID: 4775422
Drug Overview
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.

Analyst Outlook
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.

Table of Contents

OVERVIEW
Drug Overview
Product Profiles
Yescarta : NHL: Follicular lymphoma (FL)
Yescarta : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
Figure 1: Yescarta for follicular lymphoma – SWOT analysis
Figure 2: The authors drug assessment summary of Yescarta for follicular lymphoma
Figure 3: The authors drug assessment summary of Yescarta for follicular lymphoma
Figure 4: Yescarta sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 5: Yescarta for diffuse large B-cell lymphoma – SWOT analysis
Figure 6: The authors drug assessment summary for Yescarta in diffuse large B-cell lymphoma
Figure 7: The authors drug assessment summary for Yescarta in diffuse large B-cell lymphoma
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
Table 1: Yescarta drug profile
Table 2: Yescarta ongoing pivotal trial in follicular lymphoma
Table 3: Yescarta sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 4: Yescarta drug profile
Table 5: Yescarta pivotal trial data in diffuse large B-cell lymphoma
Table 6: Yescarta ongoing late-phase trial in diffuse large B-cell lymphoma
Table 7: Yescarta sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26