Idecabtagene vicleucel is under clinical development by Bristol-Myers Squibb and currently in the Phase II 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 Idecabtagene vicleucel’s likelihood of approval (LoA) and phase transition for Multiple Myeloma (Kahler Disease) took place on 06 Jun 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 Idecabtagene vicleucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Idecabtagene vicleucel overview

Idecabtagene Vicleucel (Abecma) is a B-Cell maturation antigen-directed genetically modified autologous T cell immunotherapy comprised of patient’s own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector (LVV). It is formulated as suspension and solution for intravenous route of administration. Abecma is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody and indicated for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy.

Idecabtagene vicleucel (bb-2121) is under development for the treatment of newly diagnosed multiple myeloma, relapsed and refractory multiple myeloma, mantle cell lymphoma and Burkitt’s lymphoma. The therapeutic candidate constitutes of autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen. It is administered through intravenous infusion.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

Quick View Idecabtagene vicleucel LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Idecabtagene vicleucel
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.