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SIPULEUCEL-T

FDA-approved active Cell therapy Quality 45/100

PROVENGE induces an immune response against PAP, an antigen found in most prostate cancers.

Sipuleucel-T, marketed as PROVENGE, is a unique immunotherapy for metastatic castrate-resistant prostate cancer, currently holding a niche market position. Its key strength lies in its proven mechanism of inducing an immune response against the PAP antigen, which is prevalent in most prostate cancers. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition.

At a glance

Generic nameSIPULEUCEL-T
Drug classAutologous Cellular Immunotherapy [EPC]
TargetPAP
ModalityCell therapy
PhaseFDA-approved

Mechanism of action

PROVENGE is an autologous cellular immunotherapy that aims to stimulate the immune system to target PAP, an antigen commonly present in prostate cancer cells. The drug uses a patient's own immune cells, which are exposed to PAP-GM-CSF ex vivo, leading to the processing and presentation of PAP peptides on the cell surface, thereby priming the immune system to recognize and attack cancer cells expressing PAP.

Approved indications

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results