Ibrutinib by AbbVie for Mantle Cell Lymphoma: Likelihood of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ibrutinib overview

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.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic and rheumatological diseases, neurological disorders, skin diseases, rheumatoid arthritis, pain related to endometriosis, pediatric Crohn’s disease, cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of Crohn’s disease, Parkinson’s disease, viral diseases, wet AMD, various cancers, neurological disorders, aesthetics, and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, healthcare facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

For a complete picture of Ibrutinib’s drug-specific PTSR and LoA scores, buy the report here.

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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.