Drugs / Leukine

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) LEUKINE — 1995-09-15 – 2018-03-29 fda.gov ↗
Approved US (FDA) LEUKINE — 1991-03-05 fda.gov ↗

Trials 2

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT01527422 Jan 2006 → Nov 2010 non-Hodgkin lymphoma Fernando Cabanillas Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01511068 Aug 2012 → Jul 2013 hereditary pulmonary alveolar proteinosis Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Comparator or background therapy6 trials
Phase 1/2 NCT01653665 Comparator Aug 2012 → Jan 2015 critical illness polyneuropathy, immunodeficiency disease, infectious disease with sepsis Newcastle-upon-Tyne Hospitals NHS Trust Completed No outcome recorded
Phase 1/2 NCT00785122 Background Jun 2008 → Jan 2011 colorectal carcinoma Immatics Biotechnologies GmbH Completed No outcome recorded
Phase 2 NCT04300244 Background May 2020 → Mar 2025 overdue lung cancer, malignant pleural mesothelioma Åslaug Helland Active not recruiting No outcome recorded
Phase 2 NCT00523159 Background May 2007 → Aug 2009 renal cell carcinoma Immatics Biotechnologies GmbH Completed No outcome recorded
Phase 2 NCT00176280 Background Sep 2005 → ? renal cell carcinoma University of Kentucky Withdrawn No outcome recorded Stop: Enrollment

Press releases naming this drug 29 releases

DateIssuerRelease
2025-09-09 Partner Therapeutics, Inc. 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 ↗
2025-06-20 Partner Therapeutics, Inc. 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 ↗
2025-01-09 Partner Therapeutics, Inc. BARDA and Partner Therapeutics continue partnership around development of LEUKINE® (sargramostim, rhu GM-CSF) to potentially improve patient care for sepsis partnertx.com ↗
2024-04-18 Partner Therapeutics, Inc. Comprehensive Review Highlights Potential Benefits of Leukine® in Management of Gastrointestinal (GI) Adverse Events Associated with Immune Checkpoint Inhibitors (ICIs) in the Treatment of Cancer partnertx.com ↗
2024-04-03 Partner Therapeutics, Inc. Partner Therapeutics’ Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP) partnertx.com ↗
2024-01-17 Partner Therapeutics, Inc. Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma partnertx.com ↗
2023-12-20 Partner Therapeutics, Inc. Exploratory Results Suggest the Potential Role of LEUKINE ® as a Host-Directed Immunomodulator partnertx.com ↗
2023-11-30 Partner Therapeutics, Inc. 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 ↗
2022-12-15 Partner Therapeutics, Inc. 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 ↗
2022-02-17 Partner Therapeutics, Inc. Partner Therapeutics Announces Contract with U.S. Department of Defense for Advanced Development of Leukine® to Treat Sulfur Mustard Gas (HD) Exposure partnertx.com ↗
2021-09-20 Partner Therapeutics, Inc. BARDA and Partner Therapeutics foster a new partnership around their FDA-approved drug, Leukine® to improve patient care for sepsis patients partnertx.com ↗
2021-08-17 Partner Therapeutics, Inc. “A Drug Before Its Time?” LEUKINE® systematic review highlights innate and adaptive immune activity that may improve cancer outcomes and reduce toxicity partnertx.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Leukine “escalating dose of GM-CSF (Leukine) up to 250 mcg.” NCT01527422 ↗
7

“Leukine (Sargramostim, GM-CSF)” NCT01653665 ↗

“Leukine” NCT00571662 ↗

NCT04300244 ↗

NCT00785122 ↗

NCT01511068 ↗

NCT00176280 ↗

NCT00523159 ↗

Known as GM-CSF “Leukine (Sargramostim, GM-CSF)” NCT01653665 ↗
Known as Leukine (Sargramostim) “Leukine (Sargramostim)” NCT01527422 ↗
Known as Sargramostim “Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks.” NCT01511068 ↗
1

“Leukine (Sargramostim, GM-CSF)” NCT01653665 ↗

Modality Protein / enzyme biologic “inhaled recombinant human GM-CSF” NCT01511068 ↗
Route Subcutaneous “Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)” NCT00176280 ↗