Azacitidine is under clinical development by Bristol-Myers Squibb and currently in Phase II for Pancreatic Ductal Adenocarcinoma. According to GlobalData, Phase II drugs for Pancreatic Ductal Adenocarcinoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Azacitidine LoA Report. Buy the report here.

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.

Azacitidine overview

Azacitidine (Vidaza, Azafuridine, Celazadine) is a pyrimidine analog acts as an anti-anemic, anti-neoplastic agent. It is formulated as lyophilized powder for suspension and solution for intravenous, and subcutaneous route of administration. It is indicated for the treatment of myelodysplastic syndromes (MDS). It is indicated used for all 5 FAB (French-American-British) subtypes of myelodysplastic syndromes (MDS) which include refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T) and chronic myelomonocytic leukemia (CMMoL). Vidaza is also indicated for the treatment of adult patients aged 65 years or older with acute myeloid leukemia (AML) who are not eligible for hematopoietic stem cell transplantation (HSCT) and  indicated for the treatment of adult patients who are not eligible for hematopoietic stem cell transplantation (HSCT) with intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder and acute myeloid leukemia (AML) with 20-30% blasts and multi-lineage dysplasia. Vidaza is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed JMML.

Injectable azacitidine is under development for newly diagnosed advanced myelodysplastic syndrome, myeloproliferative neoplasm, osteosarcoma, multiple myeloma and relapsed or refractory non-Hodgkin lymphoma, Hodgkin lymphoma, adult T-cell leukemia/lymphoma, extranodal NK-/T-cell lymphoma, nasal type, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like t-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, primary cutaneous T-cell lymphoma, primary cutaneous CD8+ T-cell lymphoma, transformed mycosis fungoides, primary cutaneous CD4+ small/medium T-cell lymphoproliferative disorder, follicular T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, ALK- and ALK+ anaplastic large-cell lymphoma and diffuse large b-cell lymphoma.

It was also under development for treatment of as a second line therapy for angioimmunoblastic T-cell lymphoma,  transitional cell cancer (urothelial cell cancer), epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer pancreatic cancer, nasopharyngeal carcinoma, cervical carcinoma, anal carcinoma and merkel cell carcinoma (MCC).

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in Princeton, New Jersey, the US.

For a complete picture of Azacitidine’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.