POLIVY

What it is

Polivy is a CD79b-targeted antibody-drug conjugate that preferentially binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor. Each vial is designed to deliver a total of 30 mg or 140 mg of polatuzumab vedotin. Polivy is a powder for concentrate for solution for infusion, supplied in single-dose vials as a preservative-free white to grayish-white lyophilised powder.

Approved indications

— Treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP). — Treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant, in combination with bendamustine and rituximab.

Dosing overview

The initial dose should be administered as a 90-minute intravenous infusion, and if the prior infusion was well tolerated, subsequent doses may be administered as a 30-minute infusion. An antihistamine and anti-pyretic should be administered to patients prior to administration of Polivy.

Key safety warnings

Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with Polivy as early as the first cycle of treatment. Prophylactic G-CSF administration should be considered. Complete blood counts should be monitored prior to each dose of Polivy. Peripheral neuropathy has been reported in patients treated with Polivy as early as the first cycle of treatment, and the risk increases with sequential doses. Patients with pre-existing peripheral neuropathy may experience worsening of this condition. Peripheral neuropathy reported with Polivy treatment is predominantly sensory peripheral neuropathy; however, motor and sensorimotor peripheral neuropathy have also been reported. Patients should be monitored for symptoms of peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, weakness, or gait disturbance. Serious, life-threatening, or fatal infections, including opportunistic infections, such as pneumonia (including pneumocystis jirovecii and other fungal pneumonia), bacteraemia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy. Patients should be closely monitored during treatment for signs of bacterial, fungal, or viral infections. Anti-infective prophylaxis should be considered. Progressive multifocal leukoencephalopathy (PML) has been reported with Polivy treatment. Patients should be monitored closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML. Infusion-related reactions (IRRs), including severe cases, have been observed with Polivy. IRRs can occur as late as 24 hours after receiving Polivy. Patients should be administered premedication with an antihistamine and anti-pyretic prior to administration of Polivy. Serious cases of hepatic toxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with Polivy. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Cases of tissue damage following infusion site extravasation (including severe events) have been reported in patients treated with Polivy. To minimise risk, ensure adequate venous access prior to initiating the infusion and closely monitor the infusion site throughout administration for any signs of extravasation.

Contraindications

Polivy is contraindicated in patients with a known hypersensitivity to polatuzumab vedotin or any of the excipients.

PBS listing

Information regarding PBS listing, including strength(s) listed, item count, restriction type, and ex-manufacturer price, is not available in the provided source documents.

Regulatory history

Polivy polatuzumab vedotin 140 mg powder for injection vial was first listed on the ARTG on 21 October 2019. Polivy polatuzumab vedotin 30 mg powder for injection vial was first listed on the ARTG on 10 August 2022. In November 2022, PBAC did not recommend Polivy for previously untreated diffuse large B-cell lymphoma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone. In March 2025, PBAC recommended Polivy for previously untreated diffuse large B-cell lymphoma with an international prognostic index (IPI) score of 3-5 in combination with rituximab, cyclophosphamide, doxorubicin and prednisone. Polivy is subject to additional monitoring in Australia.