Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Sasanlimab (PF-06801591): A Comprehensive Profile of a Subcutaneous PD-1 Inhibitor and its Potential to Reshape the Treatment Paradigm for Non-Muscle Invasive Bladder Cancer
Executive Summary
Sasanlimab (PF-06801591) is an investigational, humanized immunoglobulin G4 (IgG4) monoclonal antibody developed by Pfizer that functions as an immune checkpoint inhibitor by targeting the programmed cell death 1 (PD-1) receptor. Its mechanism involves blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby restoring the anti-tumor activity of the host immune system. The most significant clinical advancement for sasanlimab has been in the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-naïve non-muscle invasive bladder cancer (NMIBC). In the pivotal, multinational Phase III CREST trial, the combination of subcutaneously administered sasanlimab with standard-of-care intravesical BCG (induction and maintenance) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) compared to BCG alone. The combination therapy reduced the risk of an EFS event by 32% and showed particularly durable complete responses in patients with carcinoma in situ (CIS).
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/10/03 | Not Applicable | Not yet recruiting | |||
2025/08/14 | Not Applicable | Not yet recruiting | Stephanie Berg | ||
2025/05/16 | Phase 1 | Recruiting | |||
2025/03/11 | Phase 1 | Active, not recruiting | |||
2024/08/30 | Phase 1 | Terminated | |||
2024/08/09 | Phase 1 | Active, not recruiting | |||
2024/06/07 | Phase 1 | Terminated | |||
2024/02/29 | Phase 1 | Terminated | |||
2024/01/23 | Phase 2 | Not yet recruiting | |||
2023/10/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.