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Sasanlimab

Generic Name
Sasanlimab

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Sep 25, 2025

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).

Continue reading the full research report

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

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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No UK EMC drug information found for this drug.

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