Axicabtagene ciloleucel is under clinical development by Gilead Sciences and currently in the Phase II and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Axicabtagene ciloleucel’s likelihood of approval (LoA) and phase transition for B-Cell Non-Hodgkin Lymphoma took place on 24 Oct 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Axicabtagene ciloleucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.

Quick View Axicabtagene ciloleucel LOA Data

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

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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.