Onureg is under clinical development by Bristol-Myers Squibb and currently in Phase I for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma). According to GlobalData, Phase I drugs for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma) have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Onureg’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.

Onureg overview

Azacitidine (Onureg) is a pyrimidine analogue acts as an anti-anemic and anti-neoplastic agent. It is formulated as tablets and film-coated tablets for oral route of administration. Onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
The drug candidate is under development for the treatment of relapsed and refractory acute myeloid leukemia, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myelomonocytic leukemia, hairy cell leukemia, marginal zone lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma and lymphoplasmacytic lymphoma, peripheral T-cell lymphomas (PTCL) including angioimmunoblastic T-cell lymphoma (AITL)/immunoblastic lymphadenopathy, follicular T-cell lymphoma, myelodysplastic syndrome, non-small cell lung cancer, metastatic melanoma, solid tumors, non-Hodgkin lymphoma, Hodgkin lymphoma, diffuse large B-cell lymphoma.
It was under development for the treatment of anal cancer, Merkel cell carcinoma, cervical cancer, nasopharyngeal cancer, pancreatic cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, multiple myeloma, HPV associated nasopharyngeal cancer, liposarcoma, metastatic breast cancer.

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

This content was updated on 20 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.