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Polivy
Published
Product name
Polivy
Active ingredient
Polatuzumab vedotin
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Polivy (polatuzumab vedotin) was approved for the following therapeutic use:
Polivy in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant.
How this medicine works
Polatuzumab vedotin is a cancer treatment. Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers an anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanised immunoglobulin G1 (IgG1) monoclonal antibody via a cleavable linker. The monoclonal antibody binds with nanomolar affinity to CD79b, a cell surface component of the B cell receptor. CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in > 95% of diffuse large B-cell lymphoma (DLBCL). Upon binding CD79b, polatuzumab vedotin is internalised and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Polivy was considered favourable for the therapeutic use approved.
Sponsor