Drugs / sargramostim
sargramostim
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
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| Approved | EU (EMA) | Imreplys | — | 2025-08-21 | europa.eu ↗ |
| Label expansions (3) | US (FDA) | LEUKINE | — | 1995-09-15 – 2018-03-29 | fda.gov ↗ |
| Approved | US (FDA) | LEUKINE | — | 1991-03-05 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | SciClone Pharmaceuticals | Results 胸腺法新三项研究亮相2026 ASCO 聚焦晚期复发实体瘤、黑色素瘤及胃癌 sciclone.com ↗
结果显示，客观缓解率（ORR）为30.8%（95%CI 17.0%-47.6%），包括4例完全缓解和8例部分缓解，中位无进展生存期（PFS）为4.2个月，未报告≥3级治疗相关不良事件。 |
| 2026-06-01 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at ASCO Meeting 2026 greenwichlifesciences.com ↗
In this preliminary data analysis, there was a significant increase in percentage of patients experiencing an ISR reaction (for both erythema and induration) in vaccination 4, vaccination 5 or vaccination 6 compared to the baseline vaccination. |
| 2026-04-20 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at AACR Meeting 2026 greenwichlifesciences.com ↗
In this preliminary data analysis, there was a significant increase in percentage of patients experiencing a DTH reaction (redness) in month 4 or month 6 compared to baseline. |
| 2025-12-15 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01 greenwichlifesciences.com ↗
A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. |
| 2025-10-02 | Greenwich LifeSciences, Inc. | Regulatory Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium greenwichlifesciences.com ↗
The Company's application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US. |
| 2025-09-10 | Greenwich LifeSciences, Inc. | Regulatory Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation greenwichlifesciences.com ↗
today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. |
| 2025-09-09 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics Receives EMA Approval of IMREPLYS® (sargramostim, rhu GM-CSF) to Treat Exposure to Myelosuppressive Doses of Radiation (Hematopoietic Sub-syndrome of Acute Radiation Syndrome [H-ARS]) partnertx.com ↗ |
| 2025-08-13 | Greenwich LifeSciences, Inc. | Regulatory Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania greenwichlifesciences.com ↗
The Company's application to expand Flamingo-01 into Romania has been formally approved by European regulators, thus adding Romanian sites to the approximately 150 approved sites in Spain, France, Germany, Italy, Poland and the US. |
| 2025-06-20 | Partner Therapeutics, Inc. | Regulatory European Medicines Agency CHMP Recommends EU Approval of Partner Therapeutics IMREPLYS® (sargramostim, rhu GM-CSF) to Treat Exposure to Myelosuppressive Doses of Radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome) partnertx.com ↗ |
| 2025-04-03 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Provides Global Update on FLAMINGO-01 greenwichlifesciences.com ↗
The Company recently confirmed that the preliminary HLA prevalence, safety, and immune response data in FLAMINGO-01 patients is trending as expected in both HLA-A*02 and non-HLA-A*02 arms. |
| 2025-04-02 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial greenwichlifesciences.com ↗
The Company has analyzed the preliminary immune response data from FLAMINGO-01. |
| 2025-03-17 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01 greenwichlifesciences.com ↗
No serious adverse events related to GLSI-100 have been reported to date in FLAMINGO-01. |
| 2025-03-03 | Orphan Australia | Results Y-mAbs Announces Publication of Phase 2 Interim Results in Nature Communications serb.com ↗
Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile. |
| 2025-03-03 | Y-mAbs Therapeutics | Results Y-mAbs Announces Publication of Phase 2 Interim Results in Nature Communications ymabs.com ↗
Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile. |
| 2025-02-10 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01 greenwichlifesciences.com ↗
The HLA-A*02 prevalence of 46% in all screened patients meets our expectations of 40-50% prevalence and supports our sample size estimates for the trial and the interim analysis. |
| 2024-09-06 | Orphan Australia | Results Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research serb.com ↗
Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) achieved a disease control rate of 63%, with the results suggesting consistent disease control irrespective of baseline Curie score. |
| 2024-09-06 | Y-mAbs Therapeutics | Results Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research ymabs.com ↗
Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) achieved a disease control rate of 63%, with the results suggesting consistent disease control irrespective of baseline Curie score. |
| 2024-06-01 | Y-mAbs Therapeutics | Results Y-mAbs Announces New Interim Analysis of Phase 2 Data for Naxitamab at 2024 ASCO Annual Meeting ymabs.com ↗
Importantly, prior sensitivity to chemo-immunotherapy predicted better responses with the new combinations. |
| 2024-04-03 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics’ Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP) partnertx.com ↗ |
| 2024-02-27 | Greenwich LifeSciences, Inc. | Regulatory Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries greenwichlifesciences.com ↗
The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland. |
| 2024-02-22 | Greenwich LifeSciences, Inc. | Regulatory Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators greenwichlifesciences.com ↗
The regulators have thus approved the clinical trial, marking a major milestone for the Company. |
| 2024-01-17 | Partner Therapeutics, Inc. | Results Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma partnertx.com ↗
Leukine has been studied extensively in combination with dinutuximab and naxitamab leading to improved patient outcomes. |
| 2023-12-20 | Partner Therapeutics, Inc. | Results Exploratory Results Suggest the Potential Role of LEUKINE ® as a Host-Directed Immunomodulator partnertx.com ↗
No difference was found in the primary endpoint between treatment arms. |
| 2023-11-30 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of 30-month Randomized Open Label Study of LEUKINE® in Combination with Whole Lung Lavage for Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) partnertx.com ↗
One patient out of 9 (11%) treated with Leukine required a WLL during the 30-month period. |
| 2023-10-16 | Orphan Australia | Results Y-mAbs Announces Publication in Cancers serb.com ↗
In this study, early administration of naxitamab-based chemo-immunotherapy was shown to significantly improve long-term outcomes, addressing an important unmet need in the current treatment paradigm for this critical patient group. |
| 2023-10-16 | Y-mAbs Therapeutics | Results Y-mAbs Announces Publication in Cancers ymabs.com ↗
In this study, early administration of naxitamab-based chemo-immunotherapy was shown to significantly improve long-term outcomes, addressing an important unmet need in the current treatment paradigm for this critical patient group. |
| 2023-05-26 | Y-mAbs Therapeutics | Results Y-mAbs Announces Presentation of Naxitamab Data at ASCO ymabs.com ↗
Overall, the most common naxitamab related serious adverse events were hypotension, pain, urticaria, and bronchospasm. |
| 2022-12-15 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of a Retrospective Cohort Review of 15 LEUKINE® Treated Patients with Pediatric Malignancies and Invasive Fungal Disease Refractory to Antifungal Therapy partnertx.com ↗
The overall response rate for sargramostim use in the retrospective cohort was 92%. |
| 2022-06-28 | SciClone Pharmaceuticals | Regulatory 赛生药业旗下那西妥单抗新适应症II期临床申请获批 sciclone.com ↗
公司近日收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》（通知书编号：2022LP01001），由公司提交的“Naxitamab和粒细胞-巨噬细胞集落刺激因子联合伊立替康及替莫唑胺治疗原发难治性或首次复发的高危神经母细胞瘤”（临床试验编号：203，以下简称“203研究”）的临床试验申请获得批准。 |
| 2022-05-26 | Y-mAbs Therapeutics | Results Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint ymabs.com ↗
The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate (“ORR”) according to the International Neuroblastoma Response Criteria (“INRC”) of 30.6 |
| 2022-04-20 | SciClone Pharmaceuticals | Regulatory 赛生药业提交那西妥单抗新适应症II期临床试验申请并获受理 sciclone.com ↗
我们很高兴看到我们的临床试验申请在 CDE 也获得受理。 |
| 2021-12-15 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences CEO Participates in TD Ameritrade Interview to Discuss 2021 SABCS Poster greenwichlifesciences.com ↗
The newly published Phase IIb clinical trial data shows that 22.8% of 145 patients had an immune response to GP2 prior to any treatment with GP2. |
| 2021-08-17 | Partner Therapeutics, Inc. | Results “A Drug Before Its Time?” LEUKINE® systematic review highlights innate and adaptive immune activity that may improve cancer outcomes and reduce toxicity partnertx.com ↗
These data suggest an emerging role for sargramostim immune suppressed sepsis, refractory bacterial and fungal infections, viral respiratory infections, autoimmune pulmonary alveolar proteinosis (aPAP), neurodegenerative diseases, and in combination with immune checkpoint inhibitors. |
| 2021-06-28 | Partner Therapeutics, Inc. | Results Second Randomized Trial of Leukine® (sargramostim) in COVID-19 Demonstrates Improvement in Lung Function partnertx.com ↗
Partner Therapeutics, Inc. (PTx) announced top-line results of the U.S.-based iLeukPulm clinical trial of inhaled Leukine (sargramostim, yeast-derived recombinant human granulocyte macrophage colony stimulating factor (GM-CSF)) in hospitalized COVID-19 patients ( NCT04411680 ). |
| 2021-06-07 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Publishes Additional Positive Safety Data from GP2 Phase IIb Trial at ASCO 2021, Confirming that GP2 Treatment to Prevent Metastatic Breast Cancer Recurrence is Well Tolerated greenwichlifesciences.com ↗
Final safety conclusions are that GP2 immunotherapy is well tolerated and that no serious adverse events related to GP2 immunotherapy were reported over the full 5 year follow-up period. |
| 2021-06-04 | Y-mAbs Therapeutics | Results Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma ymabs.com ↗
The three-year event free survival (“EFS”) for patients in first CR was 74% and 19% for second or later CR. |
| 2021-05-19 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of Clinical Trial Results of Leukine® (sargramostim) in Patients with Parkinson’s Disease partnertx.com ↗
Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces the publication of results from an investigator-initiated clinical trial ( NCT03790670 ) evaluating the use of Leukine® (sargramostim, yeast-derived rhuGM-CSF) in patients with Parkinson’s Disease. |
| 2021-03-24 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of Clinical Trial Results Showing Significant Benefit with Use of Leukine® (sargramostim) in Patients with Alzheimer’s Disease partnertx.com ↗
We are excited to see that Leukine, even in the short term, can potentially be disease modifying. |
| 2021-02-26 | Partner Therapeutics, Inc. | Results SARPAC Clinical Trial of Leukine® (sargramostim, rhu GM-CSF) in Hospitalized COVID-19 Patients Meets Primary Endpoint of Significant Improvement in Lung Function partnertx.com ↗
Treatment with sargramostim was safe, well tolerated and generated T-cells targeted at the SARS-CoV-2 virus, indicating a COVID-19 specific immune response |
| 2021-02-18 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of Two Studies Demonstrating Leukine® Improves Survival in Acute Radiation Syndrome (ARS) partnertx.com ↗
Studies Showed Statistically Significant Improvements in Survival in Subjects Treated with Leukine Starting 48 Hours After Acute, High Dose Radiation Exposure without Need for Blood Transfusions or Other Forms of Intensive Supportive Care |
| 2020-12-11 | Sellas Life Sciences Group | Results SELLAS Announces Positive Follow-up Data from the Randomized Phase 2 VADIS Trial of Nelipepimut-S (NPS) in Women with Ductal Carcinoma In-Situ of the Breast sellaslifesciences.com ↗
The updated data, based on a 6-month follow-up, demonstrate that CD8+ T-cell responses persist long-term post-NPS treatment, with treated patients retaining and modestly enhancing their antigen-specific immune response. |
| 2020-12-09 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Announces Poster Presentation of Five Year Data for GP2 Phase IIb Clinical Trial, Showing 0% Recurrence of Breast Cancer greenwichlifesciences.com ↗
Kaplan Meier analysis of disease free survival for patients treated with GP2 immunotherapy shows 100% survival (0% breast cancer recurrences, p = 0.0338 ) following surgery and Herceptin treatment over median 5 years of follow-up |
| 2020-11-18 | Greenwich LifeSciences, Inc. | Results Greenwich LifeSciences Announces Publication of Positive Phase IIb Clinical Trial Data for GP2, Its Lead Drug Candidate for the Prevention of Recurring Breast Cancer greenwichlifesciences.com ↗ |
| 2019-10-25 | Y-mAbs Therapeutics | Results Y-mAbs Announces Naxitamab Update ymabs.com ↗
In this population, where 88% had previously received an anti-GD2 therapy and 30% had previously received two or more lines of anti-GD2 therapy, a two-year progression-free survival of 52% was observed. |
| 2019-09-19 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics Receives Orphan Drug Designation for Leukine® (sargramostim) partnertx.com ↗
Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Leukine® (sargramostim), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF), for the potential treatment of Stage IIb-IV melanoma. |
| 2018-11-06 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics Receives FDA Orphan Drug Designation for Leukine® for the Treatment of Pulmonary Alveolar Proteinosis partnertx.com ↗ |
| 2018-08-21 | Y-mAbs Therapeutics | Regulatory Y-mAbs Receives Breakthrough Therapy Designation for Naxitamab for the treatment of High Risk Neuroblastoma ymabs.com ↗
The FDA has granted Y-mAbs Breakthrough Therapy designation for naxitamab, in combination with GM-CSF, for the treatment of high risk neuroblastoma |
| 2018-06-06 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics (PTx) Announces US FDA Approval of Leukine® (sargramostim) for the Treatment of Acute Radiation Syndrome partnertx.com ↗
Commercial-stage cancer biotech company, Partner Therapeutics, Inc. (PTx), announced the recent FDA approval of Leukine for the treatment of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS). |
| 2017-10-27 | Xiamen Amoytop Biotech Co., Ltd. | Results 国产乙肝新药在美国大放异彩，“中国智慧”带来乙肝治愈新希望 amoytop.com ↗
中 期 分 析72周 结 果 显 示，派 格 宾 联 合 治 疗 组HBsAg清 除 率 达26%，显 著 高 于 对 照 组0%，同 时 抗 乙 肝 表 面 抗 体（HBsAb）的 阳 性 率 达18%，对 照 组 为0%. |
| 2017-10-12 | Targovax Oy | Results Targovax announces one-year survival rate and safety data in the modified cohort of the TG01 trial in resected pancreatic cancer circio.com ↗
TG01/GM-CSF generated an immune response in 85% of patients (11/13) |
| 2017-06-06 | Targovax Oy | Results Targovax presents further positive clinical data from TG01 phase I/II trial at 2017 ASCO annual meeting circio.com ↗
The data show that: TG01/GM-CSF generated early immune responses in 89% of patients (17/19) with resected pancreatic cancer. |
| 2017-02-02 | Targovax Oy | Results Targovax announces encouraging top line two-year survival data from TG01 clinical trial in resected pancreatic cancer patients circio.com ↗
Survival rate of 68% from first patient cohort vs published historical rate of 30-53% suggests signal of clinical efficacy for the drug candidate |
| 2016-06-09 | Bionor Immuno AS | Results The peer-reviewed and highly recognized journal ‘The Lancet HIV’ has accepted the results of the REDUC Part B trial for publication bionorholding.com ↗
Bionor Pharma ASA (Bionor) (OSE:BIONOR), announced today that the positive results from the clinical trial REDUC Part B (BPC01-001) will be published for the first time in the peer-reviewed and highly recognized journalThe Lancet HIV. |
| 2016-05-12 | Targovax Oy | Results Targovax ASA: Interim report first quarter 2016 circio.com ↗
During the first quarter of 2016, Targovax identified promising data from an interim survival analysis of a first cohort and conducted an interim DTH immunological response evaluation of a second cohort of a phase I/II combination study of TB01/GM-CSF and gemcitabine(chemotherapy). |
| 2016-04-14 | Targovax Oy | Results Targovax reports immune response with reduced number of TG01 vaccinations circio.com ↗
Targovax now announces, in a second part of the trial, where the overall number of vaccinations have been reduced, that 4 of the first recruited 5 patients (of a total of up to 13 patients) showed an 8-week immune response. |
| 2016-03-10 | Targovax Oy | Results Targovax announces encouraging interim results with RAS specific peptide vaccine in resected pancreatic cancer circio.com ↗
The regimen was generally well tolerated and RAS specific T-cell immune responses were induced and enhanced when TG01/GM-CSF was administered in combination with gemcitabine (1) . |
| 2016-02-23 | Bionor Immuno AS | Results The final assay in Bionor’s REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vacc-4x and romidepsin bionorholding.com ↗
With the results of this assay showing a mean 13% non-statistically significant (p=0.271) reduction, the direction of all three assays is consistent. |
| 2015-11-17 | Bionor Immuno AS | Regulatory Bionor files first clinical trial application for BIOSKILL bionorholding.com ↗
Bionor Pharma ASA (OSE:BIONOR) today announced the submission of a clinical trial application (CTA) to the Danish Medicines Agency requesting approval to initiate BIOSKILL in Denmark. |
| 2015-09-14 | Amgen | Results Amgen Highlights Key Clinical Data To Be Presented At European Cancer Congress 2015 amgen.com ↗
Clinical benefits associated with durable response (DR) in patients (pts) with unresected stage IIIB/C/IV melanoma treated with talimogene laherparepvec (T-VEC) or GM-CSF in the randomized Phase 3 OPTiM trial (NCT00769704) |
| 2015-06-01 | Targovax Oy | Results Targovax presented safety data and immunological results at the 2015 ASCO Annual Meeting circio.com ↗
The regimen was generally well tolerated with related events to TG01/molgramostim being those expected (local reactions and flu-like symptoms) for a peptide vaccine. |
| 2012-12-20 | Gliknik Inc. | Results Gliknik Announces Interim Clinical Data From Use of Its Immunomodulator Drug Candidate in Multiple Myeloma Patients gliknik.com ↗
Based on the interim analysis, researchers saw a 180-day rate of complete or partial response of 96 percent. |
| 2011-05-19 | Sutro Biopharma, Inc. | Results Study Shows Sutro Biopharma’s Biochemical Protein Synthesis Technology Enables Rapid Production and Scale-Up of Biopharmaceuticals Results Published in Biotechnology and Bioengineering Demonstrate that Cell-Free Production of a Biologically Active Human Cytokine Can be Scaled-up to Commercial Manufacturing Levels Study Featured in Journal’s Spotlight Section. sutrobio.com ↗
In the study, the fully bioactive cytokine human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was produced at linearly scalable levels from frozen extract of Sutro’s E.coli -based open cell-free synthesis (OCFS) system. |
All press releases naming this drug 76 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 343 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sargramostim | “Preliminary preclinical results demonstrated that GM-CSF (Granulocyte macrophage colony-stimulating factor, e.g. Leukine®/Sargramostim) rapidly reduced cerebral amyloid...” NCT01409915 ↗335“More recently, when dinutuximab was combined with irinotecan, temozolomide and sargramostim in patients with relapsed/refractory neuroblastoma (ANBL 1221) improved response...” NCT05421897 ↗ “Subcutaneous aldesleukin (300,000IU/m2/day) and Sargramostim (250 ug/m2 twice per week) both starting 3 days before the 1st infusion and ending 7 days after the last dose of armed ATC.” NCT01081808 ↗ “Subjects will receive GM-CSF 500μg (Sargramostim (Leukine), Sanofi Aventis) by a self-administered subcutaneous injection thrice weekly on Monday, Wednesday, and Friday for four weeks” NCT01041417 ↗ “At the same time that patients get the SurVaxM/Montanide ISA 51 injection, they will also get a second subcutaneous injection of a medicine called sargramostim.” NCT04978727 ↗ “A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy” NCT04856176 ↗ “Immunologic and Antibody Responses in Patients Receiving GM-CSF, (Leukine, Sargramostim) as Adjuvant Therapy of Stage II (T4), III and IV Melanoma.” NCT00350597 ↗ “Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma” NCT00616564 ↗ “Sargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)” NCT05366062 ↗ “autologous dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF) subcutaneously daily for 4 days” NCT00088985 ↗ “All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination.” NCT01265433 ↗ |
| Known as | GM-CSF | “OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow...” NCT00011934 ↗119“Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and...” NCT00005601 ↗ “Here, we tested our hypothesis that modulation of the innate immune system might similarly be used to treat AD in humans by investigating the ability of GM-CSF/sargramostim to...” PMID 33778150 ↗ Mar 2021 “Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF) subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43,...” NCT00265915 ↗ “OBJECTIVES: I. Determine the therapeutic effects of aerosolized sargramostim (GM-CSF) in terms of progression free survival at 2 months and median survival rate in patients...” NCT00005610 ↗ “Evaluate the effect of ketoconazole, hydrocortisone, and sargramostim (GM-CSF) on time to clinical progression in patients with prostate cancer that has progressed on primary...” NCT00309894 ↗ “Sargramostim (GM-CSF) and rituximab: Beginning approximately 7-10 weeks (49-70 days) after ASCT, patients receive GM-CSF SC 3 times a week for 8 weeks and rituximab IV once...” NCT00521014 ↗ “Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is...” NCT00027937 ↗ “Patients receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60.” NCT00002778 ↗ “GM-CSF, sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.” NCT00157573 ↗ “Sargramostim (GM-CSF) is initiated subcutaneously 1 day later and is continued for 10 days to support stem cell collections, which begin 10-14 days after CTX induction.” NCT00003007 ↗ |
| Known as | GM-CSF (sargramostim) | “GM-CSF (sargramostim)” NCT00524277 ↗ |
| Known as | granulocyte-macrophage colony-stimulating factor | “Colorectal antigen 17-1A murine monoclonal antibody, MOAB 17-1A, NSC-377963; Granulocyte-macrophage colony stimulating factor (Immunex), GM-CSF, NSC-613795.” NCT00002664 ↗6“granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).” NCT00030056 ↗ “Sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) is administered by subcutaneous injection on days 1-5 each week for 9 weeks.” NCT00003181 ↗ “the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function” NCT00000658 ↗ “sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF )” NCT00002006 ↗ “sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor)” NCT00000681 ↗ “sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF)” NCT00002070 ↗ |
| Known as | GZ402664 | “Sargramostim GZ402664” NCT02667496 ↗ |
| Known as | Leukine | “E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), will be administered in intradermal injections” NCT01479244 ↗17“Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease” NCT00206700 ↗ “Immunologic and Antibody Responses in Patients Receiving GM-CSF, (Leukine, Sargramostim) as Adjuvant Therapy of Stage II (T4), III and IV Melanoma.” NCT00350597 ↗ “Sargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)” NCT05366062 ↗ “Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer” NCT00908141 ↗ “Patients will receive hematopoietic growth factor support with either Leukine (Arm A), or Neupogen (Arm B).” NCT00237575 ↗ “Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection” NCT00228813 ↗ “CDX-110 with sargramostim (GM-CSF) (Leukine®)” NCT00458601 ↗ “Sargramostim: Leukine (Genzyme USA)” NCT02361528 ↗ “GM-CSF (Sargramostim, Leukine®)” NCT00896519 ↗ “Sargramostim (GM-CSF, Leukine)” NCT00450463 ↗ |
| Known as | Leukomax | “Sargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)” NCT05366062 ↗ |
| Known as | NSC-613795 | “Colorectal antigen 17-1A murine monoclonal antibody, MOAB 17-1A, NSC-377963; Granulocyte-macrophage colony stimulating factor (Immunex), GM-CSF, NSC-613795.” NCT00002664 ↗ |
| Known as | recombinant granulocyte-macrophage colony-stimulating factor | “adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination” NCT00000689 ↗1“sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF )” NCT00002007 ↗ |
| Known as | rhu-GM-CSF | “Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF)” NCT04446052 ↗6“Leukine® (rhu-GM-CSF)” NCT01704781 ↗ |
| Action | Activate | “Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system” NCT00006385 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant human GM-CSF is a human protein” NCT00000694 ↗ |
| Route | Subcutaneous | “IFN-A2b and GM-CSF are given in two separate injections under the skin (subcutaneous injection) once a day” NCT00000694 ↗ |