Development Pipeline

Development Pipeline

Pivotal Trial
Development Trial

ROLONTIS® (eflapegrastim)

An investigational long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia. The Biologics License Application (BLA) was filed in December, 2019, with a PDUFA date of October 24, 2020.

  • Chemotherapy-Induced Neutropenia (RECOVER, ADVANCE)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Same-Day Dosing
    Note: the Same-Day Dosing study is not included in the BLA.
    Preclinical Phase 1 Phase 2 Phase 3 Approved
For more information click here.

Poziotinib

An investigational orally administered, irreversible tyrosine kinase inhibitor (TKI) for the treatment of solid tumors.


ZENITH 20 Trial

  • Cohort 1: Previously treated EGFR exon 20 insertion mutation positive non-small cell lung cancer (NSCLC)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 2: Previously treated HER2 exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 3: Treatment naïve EGFR exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 4: Treatment naïve HER2 exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 5: Previously treated or treatment naïve EGFR or HER2 exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 6: Previously first-line osimertinib treated NSCLC with acquired EGFR mutations
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Cohort 7: Previously treated atypical EGFR or HER2 mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
For more information click here.

FIT Platform (Focused Interferon Therapeutics)

An investigational targeted platform for alpha interferon (IFN-α) for refractory tumors.

  • Interferon/CD20 Monoclonal Antibody Fusion Protein (IGN002)
    Preclinical Phase 1 Phase 2 Phase 3 Approved