Brentuximab vedotin is under clinical development by Seagen and currently in the Phase I, 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 Brentuximab vedotin’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 19 Aug 2021, 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 Brentuximab vedotin Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Brentuximab vedotin overview

Brentuximab vedotin (Adcetris) is an anti-neoplastic agent. It is formulated as a lyophilized powder for solution, solution for intravenous route of administration. Brentuximab vedotin is indicated for the treatment of patients with Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. It is indicated for the treatment of patients with Classical HL at high risk of relapse or progression as post-auto-HSCT consolidation. It is also indicated for the treatment of patients with Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is also indicated for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT), also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma, for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, for the treatment of adult patients with relapsed or refractory CD30+ cutaneous T- cell lymphoma (CTCL) after at least 1 prior systemic therapy. Adcetris is indicated for the first-line pediatric treatment for CD30-positive Hodgkin lymphoma.

Adcetris is under development for treatment of relapsed or refractory metastatic squamous or nonsquamous non-small cell lung cancer, head and neck cancer squamous cell carcinoma, metastatic cutaneous melanoma, relapsed and refractory follicular lymphoma, systemic mastocytosis and mast cell leukemia, relapsed CD30-positive cutaneous peripheral T-cell lymphoma including non systemic anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, hepatosplenic T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract, follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype, non-Hodgkin lymphoma (NHL), third line therapy in diffuse large b-cell lymphoma (DLBCL), T-cell lymphomas and for the retreatment of adult patients with who previously responded to ADCETRIS and who later relapse, adult T-cell leukemia/lymphoma. It is under development for CD30-positive malignancies other than lymphoma, multiple myeloma, acute Graft vs. Host Disease (GvHD), relapsed and refractory peripheral T-cell lymphoma, lymphomatoid papulosis (LyP), CD30-positive primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), Hodgkin's lymphoma relapsed non-Hodgkin lymphoma, other lymphomas and CD30+ Hodgkin lymphoma, and it is indicated in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, and for the treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine). Adcetris is also indicated in combination with CHP (cyclophosphamide, doxorubicin, prednisone) chemotherapy for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30.

It is under development for the treatment of malignant mesothelioma, Sezary syndrome and diffuse cutaneous systemic sclerosis. It was also under development for the treatment of testicular germ-cell cancer, relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) and systemic lupus erythematosus. Acute myelocytic leukemia, diffuse large B-Cell lymphoma and follicular Lymphoma and acute lymphoid leukemia, acute myeloid leukemia and mycosis fungoides, human immunodeficiency virus (HIV) infections and primary mediastinal B-cell lymphoma.

Seagen overview

Seagen, formerly Seattle Genetics, is a biotechnology company that discovers, develops, and markets monoclonal antibody-based therapies for the treatment of cancer. It markets antibody-drug conjugates (ADCs), including Adcetris (brentuximab vedotin), for the treatment of Hodgkin’s lymphoma, T-cell lymphomas and CD30-expressing lymphomas; Padcevtm (enfortumab vedotin-ejfv) for metastatic urothelial cancers; Tukysa (tucatinib) for the treatment of metastatic HER2-positive breast cancers, and Tivdak (tisotumab vedotin-tftv) for the treatment of certain metastatic cervical cancers. The company’s pipeline consists of novel therapies for addressing the unmet medical needs of blood-related cancers and solid tumors. Seagen products and pipeline are based on ADC technology, which targets monoclonal antibodies and delivers agents for killing cancer cells. The company sells its products through specialty distributors. Seagen is headquartered in Bothell, Washington, the US.

Quick View Brentuximab vedotin LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Brentuximab vedotin
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Gastrointestinal
  • Immunology
  • Infectious Disease
  • 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.