ROLONTIS® (eflapegrastim) is an investigational granulocyte-colony stimulating factor (G-CSF) analog. It comprises two protein components—an analog of G-CSF and an Fc antibody fragment—tethered by a flexible polyethylene-glycol linker.
> To read the latest news about eflapegrastim, or to watch a video on its mechanism, click here.
ROLONTIS® (eflapegrastim) data suggest that the human IgG4-derived Fc fragment of eflapegrastim interacts with a specific Fc receptor called FcRn, which is expressed in endothelial cells and in bone marrow, and is thought to prolong its retention in these tissues.
ROLONTIS® (eflapegrastim) is an investigational drug not approved by the FDA.
Being evaluated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been InitiatedRead More
Spectrum Pharmaceuticals Provides Update on ROLONTIS® (eflapegrastim) Pre-Approval InspectionRead More
Spectrum Pharmaceuticals Announces that the FDA is Deferring its Action on the BLA for ROLONTIS® (eflapegrastim)Read More
Spectrum Pharmaceuticals Presents Same Day Dosing Data for ROLONTIS® (eflapegrastim) at AACR Virtual Annual Meeting IIRead More
Spectrum Pharmaceuticals Initiates Same Day Dosing Clinical Trial for ROLONTIS® (eflapegrastim)Read More
Spectrum Pharmaceuticals Announces Submission to the U.S. Food and Drug Administration of Updated Biologics License Application for ROLONTIS®Read More
Spectrum Pharmaceuticals Announces Integrated Results from Two Phase 3 ROLONTIS® (eflapegrastim) Trials Being Presented at the ASCO Annual MeetingRead More
Spectrum Pharmaceuticals Announces Submission of Biologics License Application to the FDA for ROLONTIS® (eflapegrastim) as a Treatment for Chemotherapy-Induced NeutropeniaRead More
Spectrum Pharmaceuticals Announces Results from the RECOVER Phase 3 Study of ROLONTIS® (eflapegrastim) at the 2018 SABCS Annual MeetingRead More
Spectrum Pharmaceuticals Presents ADVANCE Phase 3 ROLONTIS® (eflapegrastim) Data at MASCC 2018 and Announces the Phase 3 RECOVER Study Met the Primary EndpointRead More
Spectrum Pharmaceuticals to Host Conference Call Highlighting ROLONTIS® (eflapegrastim) Phase 3 ADVANCE Study Data Presented at Multinational Association of Supportive Care in Cancer (MASCC)Read More
CORRECTING and REPLACING Spectrum Pharmaceuticals Announces Detailed Results from Phase 3 Study of ROLONTIS®(eflapegrastim) Published in an ASCO AbstractRead More
Spectrum Pharmaceuticals Announces ROLONTIS™ (eflapegrastim) Met the Primary Endpoint in the Phase 3 ADVANCE StudyRead More
Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim), a Novel Long-Acting GCSFRead More
Spectrum Pharmaceuticals Highlights ROLONTIS® (eflapegrastim) Data of ROLONTIS™ (eflapegrastim) at the American Association for Cancer Research (AACR) Annual MeetingRead More
Spectrum Pharmaceuticals Highlights Five Abstracts on ROLONTIS™ (eflapegrastim) and Poziotinib at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, December 6-10, 2016Read More
Spectrum Pharmaceuticals Begins Enrolling Patients in Registrational Trial of eflapegrastim, a Novel, Long Acting G-CSF in Patients with Breast CancerRead More
Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Registrational Trial of eflapegrastim, a Novel, Long Acting G-CSF in Patients with Breast CancerRead More