Likelihood of Approval and Phase Transition Success Rate Model – Ibrutinib in Follicular Lymphoma

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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.

Ibrutinib in Follicular Lymphoma Drug Details:

Ibrutinib (Imbruvica) is an anti-neoplastic agent. It is formulated as hard gelatin capsules, tablets, film coated tablets and suspension for oral route of administration. Ibrutinib is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with 17p deletion and for the treatment of patients with Waldenström’s macroglobulinemia (WM). It is also indicated for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutationin patients unsuitable for chemo-immunotherapy, Waldenstrom’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy, for the treatment of small lymphocytic lymphoma (SLL), as a first-line treatment for patients with chronic lymphocytic leukemia (CLL), for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion. Imbruvica is now approved for all patients with CLL, expanding the number of patients who may benefit from this treatment. Imbruvica as a single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia (CLL), for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy and in combination with obinutuzumab is indicated in adults for the treatment of naive patients with active chronic lymphocytic leukemia (CLL). Imbruvica (ibrutinib) in combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).Ibrutinib (PCI-32765) is under development for treatment of Coronavirus disease 2019 (COVID-19) infectious disease caused by severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2), her2-positive metastatic breast cancer ( third line ), splenic, extranodal and nodal marginal zone lymphoma (MZL), relapsed and refractory classical Hodgkin lymphoma, pediatric and adolescent patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy, B-cell malignancies (including relapsed and refractory chronic lymphocytic leukemia (CLL),mantle cell lymphoma, small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia, untreated Waldenström’s macroglobulinemia (WM), indolent non-Hodgkin lymphoma, treatment-naive, relapsed and refractory follicular lymphoma (FL), hairy cell leukemia, T-cell lymphoma, primary CNS lymphoma, secondary CNS lymphoma, non small cell lung cancer, multiple myeloma (second and third line), relapsed and refractory marginal zone lymphoma, refractory or steroid-dependent graft versus host disease, recurrent head and neck squamous cell carcinoma, metastatic pancreatic adenocarcinoma,  renal cell carcinoma, urothelial carcinoma, colorectal cancer, gastric or gastro-esophageal junctional adenocarcinoma, refractory myelodysplastic syndrome, relapsed and refractory acute lymphocytic leukemia (ALL), metastatic melanoma, and glioblastoma multiforme. ibrutinib in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica is indicated for the treatment of relapsed/refractory primary macroglobulinemia and lymphoplasmacytic lymphoma.It was also under development for rheumatoid arthritis and relapsed or refractory precursor B lymphoblastic leukemia (B-ALL), Burkitt lymphoma and systemic mastocytosis.

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.

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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