Development Pipeline

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