Development Pipeline

Eflapegrastim

An investigational long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia. The Biologics License Application (BLA) was originally filed in December, 2019. The company has resubmitted the Biologics License Application (BLA) with an expected six-month review for eflapegrastim following remediation of manufacturing deficiencies.

• Chemotherapy-Induced Neutropenia (RECOVER, ADVANCE)
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Same-day dosing
  
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Pediatric patients treated with myelosuppressive chemotherapy
  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.

• Previously treated EGFR exon 20 insertion mutation positive non-small cell lung cancer (NSCLC)
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Previously treated HER2 exon 20 insertion mutation positive NSCLC
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Treatment naïve EGFR exon 20 insertion mutation positive NSCLC
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Treatment naïve HER2 exon 20 insertion mutation positive NSCLC
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Previously first-line osimertinib treated NSCLC with acquired EGFR mutations (Exploratory)
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Previously treated atypical EGFR or HER2 mutation positive NSCLC (Exploratory)
  Preclinical Phase 1 Phase 2 Phase 3 Approved
• Patients with EGFR or HER2 activating mutations in advanced malignancies
  Preclinical Phase 1 Phase 2 Phase 3 Approved

For more information click here.