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Sargramostim - Bayer HealthCare Pharmaceuticals

Drug Profile

Sargramostim - Bayer HealthCare Pharmaceuticals

Alternative Names: BI 61012; GZ 402664; Leukine; Leukine Liquid; Prokine; Recombinant human GM‑CSF; rhuGM-CSF; sargramostim-biosimilar

Latest Information Update: 12 Nov 2019

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At a glance

  • Originator Amgen
  • Developer Bayer HealthCare Pharmaceuticals Inc.; Cincinnati Children's Hospital Medical Center; National Cancer Institute (USA); National Institute on Aging; Partner Therapeutics; Sanofi Genzyme; University of California at Irvine; University of California at San Francisco; University of Colorado at Denver; University of Texas M. D. Anderson Cancer Center; Virginia Commonwealth University
  • Class Adjuvants; Chemoprotectants; Granulocyte-macrophage colony-stimulating factors
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants; Macrophage stimulants; Neutrophil stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Malignant melanoma; Pulmonary alveolar proteinosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute radiation syndrome; Bone marrow disorders; Neutropenia; Pneumococcal infections; Stem cell mobilisation
  • Phase II Alzheimer's disease; Chronic lymphocytic leukaemia; Malignant melanoma; Prostate cancer; Pulmonary alveolar proteinosis
  • No development reported Ovarian cancer
  • Discontinued Crohn's disease; Follicular lymphoma; Non-Hodgkin's lymphoma

Most Recent Events

  • 23 Sep 2019 Safety and efficacy data from a phase II trial in Malignant melanoma released by Partner Therapeutics
  • 19 Sep 2019 Sargramostim receives Orphan Drug status for Malignant melanoma in USA
  • 28 Apr 2019 No recent reports of development identified for phase-I development in Prostate-cancer in USA (SC, Injection)
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