Pomalidomide is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Pomalidomide’s likelihood of approval (LoA) and phase transition for Myelodysplastic Syndrome took place on 19 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Pomalidomide Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Pomalidomide overview

Pomalidomide (Pomalyst / Imnovid) is a derivative of thalidomide and is an immunomodulatory imide drug (IMiD). It is formulated as hard gelatin capsules for oral route of administration. It is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Pomalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma. Pomalyst in combination with dexamethasone and bortezomib is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen that included lenalidomide, and it is indicated for adult patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.

Pomalidomide is under development for the treatment of acute leukemia, myelodysplastic syndrome, pediatric glioblastoma, systemic AL amyloidosis, relapsed/refractory Waldenstrom macroglobulinemia, post-polycythemia vera myelofibrosis, glioblastoma, high-grade glioma, medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG). The drug candidate was also under development for the treatment of metastatic adenocarcinoma of the pancreas, soft tissue sarcoma, metastatic hormone-refractory prostate cancer, systemic sclerosis (scleroderma), chronic cough and small-cell lung cancer. It was under development for acute myelocytic leukemia, primary myelofibrosis (chronic idiopathic myelofibrosis) and post-essential thrombocythaemia myelofibrosis.

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, hospitals, medical professionals 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 New York City, New York, the US.

Quick View Pomalidomide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Pomalidomide
Administration Pathway
  • Oral
Therapeutic Areas
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Oncology
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.