Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06439535 · 1 trial · 1 indication
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| A = PF-06439535 | EXPERIMENTAL | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| B = Bevacizumab-EU | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| C = Bevacizumab-US | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| Name | Type | Description |
|---|---|---|
| PF-06439535 | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
| Avastin | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
Inclusion Criteria: * Healthy male subjects 21-55 years old * Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug...
PF-06439535 is an investigational monoclonal antibody developed by Pfizer, Inc. (NYSE: PFE). It is a proposed biosimilar candidate to bevacizumab, studied in a Phase 1 pharmacokinetic trial comparing it with bevacizumab in healthy male volunteers. Pfizer has not publicly disclosed the specific therapeutic indications being pursued for PF-06439535.
PF-06439535 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the Phase 1 pharmacokinetic study of PF-06439535 in the United States.
PF-06439535 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
PF-06439535 has been evaluated in one completed Phase 1 trial, NCT02031991, titled "A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)." The trial enrolled 102 healthy male volunteers in the United States and was randomized, double-blind, and active-controlled.
No. PF-06439535 is a separate investigational monoclonal antibody developed by Pfizer as a proposed biosimilar to bevacizumab. The two are distinct products, and PF-06439535 has been compared directly with bevacizumab in a Phase 1 pharmacokinetic study.