Polivy

Diffuse large B-cell lymphoma (DLBCL) — previously untreated, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP); Relapsed or refractory DLBCL — after at least two prior therapies, in combination with bendamustine and rituximab

Previously untreated DLBCL (pola-R-CHP): 1.8 mg/kg IV on Day 1 of each 21-day cycle for 6 cycles
Relapsed/refractory DLBCL (with BR): 1.8 mg/kg IV on Day 1 of each 21-day cycle for 6 cycles
Infuse over 90 minutes for first infusion; may reduce to 30 minutes if tolerated
Pre-medication: Antipyretic, antihistamine before each infusion

For injection: 30 mg, 140 mg lyophilized powder in single-dose vials

None listed.

• Peripheral Neuropathy: 40% (pola-R-CHP). Primarily sensory. Monitor and dose-modify for Grade 2+ with pain or Grade 3.
• Myelosuppression: Grade 3-4 neutropenia 28% (pola-R-CHP). Febrile neutropenia 13%. Monitor CBC and consider G-CSF.
• Serious/Opportunistic Infections: Including PML. Fatal and serious infections reported. Monitor and treat.
• Progressive Multifocal Leukoencephalopathy (PML): Fatal cases. Consider PML in patients with new neurological symptoms.
• Tumor Lysis Syndrome: Monitor patients with high tumor burden.
• Hepatotoxicity: 11% Grade 3-4 transaminase elevations. Monitor LFTs.
• Embryo-Fetal Toxicity

Peripheral neuropathy (40%), nausea (29%), fatigue (27%), diarrhea (26%), neutropenia (28%), constipation (20%), decreased appetite (18%), vomiting (17%), pyrexia (17%), anemia (14%), thrombocytopenia (13%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Polatuzumab vedotin is an antibody-drug conjugate comprising a humanized anti-CD79b IgG1 antibody conjugated to MMAE (monomethyl auristatin E) via a cleavable MC-vc-PAB linker. CD79b is a B-cell–specific component of the B-cell receptor signaling complex expressed on most B-cell malignancies. Upon binding CD79b, the ADC is internalized and MMAE is released, which disrupts the microtubule network, inducing cell cycle arrest at G2/M and apoptosis.

Half-life: approximately 12 days (ADC). Steady-state by Cycle 3. MMAE is primarily metabolized by CYP3A4. Primarily excreted in feces.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• POLARIX — Pola-R-CHP vs. R-CHOP in 1L DLBCL. Phase III, n=879.
  🔬 NCT03274492 ↗ 📄 Primary Publication ↗

Polivy has FDA-approved indications across the following cancer types covered on PipelineEvidence: