Axicabtagene ciloleucel is a Gene-Modified Cell Therapy owned by Gilead Sciences, and is involved in 32 clinical trials, of which 6 were completed, 22 are ongoing, and 4 are planned.

Yescarta, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Anti-CD19 CAR T cell engagement with CD19-expressing target cells, causes the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.

The revenue for Axicabtagene ciloleucel is expected to reach a total of $987m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Axicabtagene ciloleucel NPV Report.

Axicabtagene ciloleucel was originated by Cabaret Biotech and is currently owned by Gilead Sciences. Daiichi Sankyo is the other company associated in development or marketing of Axicabtagene ciloleucel.

Axicabtagene ciloleucel Overview

Axicabtagene ciloleucel (KTE-C19 / Yescarta) is human culture expanded genetically modified autologous T cells for cell-based gene therapy. Cells are derived from isolated blood of the patient and are transduced with non-replicative retroviral vector encoding the FMC63 anti-CD19 single chain variable fragment (scFv) CD28/CD3zeta chimeric antigen receptor (FMC63-28Z CAR). It is formulated as suspension for intravenous route of administration. Yescarta is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. It is also indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is indicated for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

It is under development for the treatment of solid tumors, indolent non-Hodgkin lymphoma, diffuse large B cell lymphoma (DLBCL), lymph node and extranodal marginal zone B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma,  high grade B-cell lymphoma and large cell lymphoma. It was also under development for the treatment acute lymphoblastic leukemia and mantle cell lymphoma.

Daiichi Sankyo Overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies, and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,044,892 million for the fiscal year ended March 2022 (FY2022), an increase of 8.6% over FY2021. In FY2022, the company’s operating margin was 7.1%, compared to an operating margin of 7% in FY2021. In FY2022, the company recorded a net margin of 6.4%, compared to a net margin of 7.9% in FY2021. The company reported revenues of JPY327,480 million for the second quarter ended September 2022, an increase of 16.8% over the previous quarter.

Quick View – Axicabtagene ciloleucel

Report Segments
  • Innovator (NME)
Drug Name
  • Axicabtagene ciloleucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.