Sargramostim is under clinical development by Partner Therapeutics and currently in the Phase I, Phase II and Phase III 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 Sargramostim’s likelihood of approval (LoA) and phase transition for Metastatic Melanoma took place on 27 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Sargramostim overview

Sargramostim (Leukine, Interberin) is a recombinant granulocyte macrophage colony-stimulating factor (rhu GM-CSF). It is formulated as injection for subcutaneous, intravascular or intravenous route of administration. It is indicated for the treatment of acute myelogenous leukemia (AML) patients following the induction chemotherapy, It is also used in mobilization and after autologous peripheral blood progentior cells transplantation as well as for myeloid reconstitution following the autologous and allogeneic bone marrow transplantation, for the treatment of patients who have undergone allogeneic or autologous bone marrow transplantation (BMT) in whom engraftment is delayed or has failed and it indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

Sargramostim is under development for non-small cell lung cancer, solid tumor, mild cognitive impairment due to Alzheimer's disease, and pulmonary alveolar proteinosis in Japan and metastatic melanoma in the US. It is also under development for the treatment of acute respiratory failure associated with COVID-19, down syndrome, myelosuppressive effects of HD exposure and T cell replete HLA-mismatched haploidentical stem cell transplant recipients who are receiving post-transplant cyclophosphamide. It was also under development for the treatment of Crohn's disease, HER-2 positive breast cancer, solid tumor and Parkinson's disease.

Partner Therapeutics overview

Partner Therapeutics develop and commercializes cancer medicines and combination therapies. The company is headquartered in Lexington, Massachusetts, the US.

Quick View Sargramostim LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Sargramostim
Administration Pathway
  • Inhalational
  • Intravascular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Oncology
  • Respiratory
  • Toxicology
Key Developers
  • Sponsor Company: Partner Therapeutics
  • Originator: Immunex
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.