Drug Profile


Alternative Names: Granulocyte colony-stimulating factor long-acting - Hanmi Pharmaceutical/Spectrum; Granulocyte colony-stimulating factor long-acting - Spectrum Pharmaceuticals; HM-10460A; HNK-460; LAPS-GCSF; Long-acting G-CSF analogue; ROLONTIS; SPI-2012

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Hanmi Pharmaceutical
  • Developer Hanmi Pharmaceutical; Spectrum Pharmaceuticals
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Immunoglobulin Fc fragments; Polyethylene glycols; Small molecules
  • Mechanism of Action Granulocyte colony stimulating factor stimulants
  • Orphan Drug Status

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

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Phase III Neutropenia

Most Recent Events

  • 06 Dec 2016 Efficacy, pharmacokinetics and immunogenicity data from a phase II trial in Neutropenia (Chemotherapy-induced) presented at the 39th Annual San Antonio Breast Cancer Symposium (SABCS-2016)
  • 03 Nov 2016 Spectrum Pharmaceuticals plans a phase III trial for Neutropenia (Chemotherapy-induced) in Europe
  • 01 Nov 2016 Spectrum Pharmaceuticals plans the phase III RECOVER trial for Neutropenia (Chemotherapy-induced) in USA (SC) (NCT02953340)
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