Likelihood of Approval and Phase Transition Success Rate Model – Onureg in Relapsed Acute Myeloid Leukemia
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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Onureg in Relapsed Acute Myeloid Leukemia Drug Details:
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 newly diagnosed, relapsed and refractory acute myeloid leukemia, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myelomonocytic 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, hairy cell leukemia.
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
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