Likelihood of Approval and Phase Transition Success Rate Model – Everolimus in Myelodysplastic Syndrome
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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.


Everolimus in Myelodysplastic Syndrome Drug Details:
Everolimus (Afinitor, Votubia, RAD001) is an ester of the macrocytic immunosuppressive agent and acts as an anti-neoplastic agent. It is formulated as tablets, pills for oral route of administration. It is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole, adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic, adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib, adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery, and for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.The drug candidate is under development for the treatment of endometrial cancer, diffuse large B-cell lymphoma, low grade glioma, high-grade glioma (HGG), medulloblastoma, CNS embryonal tumor, ependymoma, diffuse intrinsic pontine glioma (DIPG), metastatic castrate-resistant prostate cancer, radioiodine-refractory thyroid cancer (papillary, follicular, medullary Hurthle cell), peripheral nerve sheath tumor, acute lymphocytic leukemia, relapsed or refractory acute myelocytic leukemia, myelodysplastic syndrome. It was also under development for the treatment of metastatic renal cell carcinoma, HER2 positive breast cancer, hepatocellular carcinoma, gastric cancer, chronic myelocytic leukemia (chronic myeloid leukemia), gastrointestinal stromal tumor, glioblastoma multiforme, non-small cell lung cancer, myeloblastic syndrome, metastatic colorectal cancer, urothelial cell cancer, progressive intracranial meningioma, relapsed or refractory cutaneous T-cell lymphoma, relapsed and refractory seminomatous, non-seminomatous germ cell cancers and advanced nonfunctional neuroendocrine tumors of gastrointestinal or lung origin and cervical cancer advanced squamous cell carcinoma of head and neck, ovarian cancer, peritoneal cancer, fallopian cancer. It was also underdevelopment for bone or soft tissue sarcoma including liposarcoma, synovial sarcoma, vestibular schwannoma, malignant paraganglioma, fibrosarcoma, gastrointestinal stromal tumor, leiomyosarcoma, angiosarcoma including haemangiopericytoma, miscellaneous sarcoma including mixed mesodermal tumors of the uterus osteosarcoma, Ewing’s sarcoma, refractory, rhabdomyosarcoma, alveolar soft part sarcoma (ASPS) and Waldenstrom macroglobulinemia. It was also under development for the treatment of epilepsy in children with Sturge-Weber Syndrome (SWS).
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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