Likelihood of Approval and Phase Transition Success Rate Model – Lisocabtagene Maraleucel in Chronic Lymphocytic Leukemia (CLL)
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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Lisocabtagene Maraleucel in Chronic Lymphocytic Leukemia (CLL) Drug Details:
Lisocabtagene maraleucel (Breyanzi) is a CD19-directed genetically modified autologous T cell immunotherapy administered as a defined composition of chimeric antigen receptor (CAR) -positive viable T cells. It is formulated as suspension for intravenous route of administration. Breyanzi is 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) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. Lisocabtagene maraleucel (JCAR-017) is under development for the treatment of as a second and third line therapy for B-cell non-Hodgkin lymphoma includes transformed follicular lymphoma (TFL), double/triple-hit lymphoma [DHL/THL], follicular lymphoma grade 3b [FL3B], 1L high grade B-cell lymphoma, splenic marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, primary central nervous system lymphoma [PCNSL] and Richter’s transformation, acute lymphoblastic leukemia (ALL) and relapsed or refractory indolent lymphoma, follicular lymphoma and mantle cell lymphoma. It is administered intravenously. The therapeutic candidate comprises of isolated T cells transduced with a lentivirus expressing CAR (chimeric antigen receptor) containing an anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of the human epidermal growth factor receptor (EGFRt).
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
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