Tisagenlecleucel is under clinical development by Novartis and currently in the Phase II and Phase III 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 Tisagenlecleucel’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 Tisagenlecleucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tisagenlecleucel overview

Tisagenlecleucel (Kymriah) is a CD19-directed genetically modified autologous of T cell immunotherapy comprised of autologous T cells that are genetically modified using a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR), acts as antineoplastic agent. It is formulated as injectable suspension for intravenous route of administration. Kymriah indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is also indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL),  refractory to treatment or relapse after two prior lines follicular lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma and relapsed or refractory ALL. Kymriah is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Tisagenlecleucel (CTL-019, CART-19) is under development for the treatment of primary central nervous system lymphoma, relapsed or refractory B-cell acute lymphoblastic leukemia, hematological malignancies including leukemia and lymphomas such as Burkitt lymphoma, marginal zone lymphoma, non-Hodgkin lymphoma, multiple myeloma, B-cell lymphomas including diffuse large B-cell lymphoma, gray zone lymphoma, small lymphocytic lymphoma, relapsed or refractory diffuse large B-cell lymphoma primary mediastinal B-cell lymphoma and refractory to treatment or relapse after two prior lines follicular lymphoma.

It was under development for treatment of mantle cell lymphoma, relapsed and refractory chronic lymphocytic leukemia and B-cell acute lymphocytic leukemia.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Tisagenlecleucel LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tisagenlecleucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Novartis
  • Originator: University of Pennsylvania
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.