Sargramostim is under clinical development by Partner Therapeutics and currently in Phase II for Hematopoietic Stem Cell Transplantation. According to GlobalData, Phase II drugs for Hematopoietic Stem Cell Transplantation have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sargramostim’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.

Sargramostim overview

Sargramostim (Leukine, Interberin, Sargmalin) is a recombinant granulocyte macrophage colony-stimulating factor (rhu GM-CSF). It is formulated as injection for subcutaneous, intravascular or intravenous, powder for solution for inhalation 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]). Sargmalin was indicated for lung disease pulmonary alveolar proteinosis in Japan.

Sargramostim is under development for non-small cell lung cancer, solid tumor, mild cognitive impairment due to Alzheimer's disease and metastatic melanoma in the US. It is also under development for the treatment of  non-tuberculous mycobacterial disease, autoimmune pulmonary alveolar proteinosis, 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.

For a complete picture of Sargramostim’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 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.