Venetoclax is under clinical development by AbbVie and currently in Phase I for Ewing Sarcoma. According to GlobalData, Phase I drugs for Ewing Sarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Venetoclax LoA Report. Buy the report here.

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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.

Venetoclax overview

Venetoclax (ABT-199, GDC-0199/RG7601, Venclexta, Venclyxto) acts as an antineoplastic agent. It is formulated as film coated tablets and coated tablets for oral route of administration. Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor, and Venclyxto in combination with rituximab is indicated for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. It is used as monotherapy in adults for the treatment of chronic lymphocytic leukemia (CLL), a 1 7p – deletion or TP53 having mutation and under a treatment with an inhibitor of the B – showed a treatment failure cell receptor signaling pathway, and also indicated in combination with azacitidine, ordecitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy and indicated for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Venclexta is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta is indicated for the treatment of acute myeloid leukemia (AML). 
It is under development for the treatment of newly diagnosed Ph-like B cell acute lymphoblastic leukemia, relapsed or refractory light chain amyloidosis, relapsed and refractory mantle cell lymphoma, small cell lung cancer, acute myeloid leukemia, follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), newly diagnosed marginal zone lymphoma, acute myeloid leukemia in first remission after conventional chemotherapy, nom-small cell lung cancer as first line therapy, primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma and extranodal MALT lymphoma, diffuse large B-cell lymphoma, frontline, relapsed or refractory myelodysplastic syndrome, DLBCL, metastatic breast cancer, t-cell acute lymphocytic leukemia  and relapsed and refractory chronic lymphocytic leukemia (CLL), solid tumors, rhabdomyosarcoma, Ewing sarcoma, Wilms' tumor (nephroblastoma). It was also under development for follicular lymphoma as first line therapy. It is a new molecular entity (NME).
It was under development for non-small cell lung cancer and angioimmunoblastic T-cell lymphoma (AITL).
It was also under development for the treatment of human epidermal growth factor receptor 2 negative breast cancer (her2- breast cancer) and relapsed and refractory multiple myeloma.

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 Venetoclax’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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.