SPPI

ROLONTIS® (eflapegrastim)

Chemotherapy-Induced Neutropenia

FDA's BLA Decision

Exp Date

TBD

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: ROLONTIS® (eflapegrastim) in Chemotherapy-Induced Neutropenia  - FDA's BLA Decision

  • ClinicalTrial.gov (NCT02953340): SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Patients With Docetaxel and Cyclophosphamide


WHAT IS THE NEXT CATALYST EVENT?

  • FDA's BLA Decision


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD


PRIOR DATA

PRESS RELEASES

MECHANISM OF ACTION / RATIONALE

  • 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 (Learn more HERE). 

Updated by HC

SPPI, Chemotherapy-Induced Neutropenia , Neutropenia, ROLONTIS, eflapegrastim)

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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