Polatuzumab vedotin in combination with R-CHP granted FDA approval for patients with untreated DLBCL

On April 19, 2023, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to polatuzumab vedotin, an antibody-drug conjugate, in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisolone) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL)-not otherwise specified or high-grade B-cell lymphoma who have an International Prognostic Index score of ≥2.¹

Polatuzumab vedotin in combination with bendamustine and rituximab was previously granted accelerated approval by the U.S. FDA for the treatment of relapsed/refractory (R/R) DLBCL after at least two prior lines of therapy. Following the FDA Oncologic Drugs advisory committee (ODAC) vote (recently discussed by Grzegorz Nowakowski on the Lymphoma Hub) and results from the phase III POLARIX study (NCT03274492), the FDA has granted approval to polatuzumab vedotin plus R-CHP as a first-line treatment for DLBCL.¹ In the POLARIX study, improvements in progression-free survival were seen with polatuzumab vedotin in combination with R-CHP compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), with the R-CHP combination showing a 27% reduced risk of disease progression, relapse, or death.¹ The adverse event profiles were comparable (Table 1). The most common AEs were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis; the most common Grade 3–4 AEs were lymphopenia and neutropenia.¹

Table 1. Safety profile of polatuzumab vedotin combined with R-CHP vs R-CHOP*

AE, adverse event; R-CHP, rituximab, cyclophosphamide, doxorubicin, and prednisolone; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. *Data from Bussinesswire.1
AE	Polatuzumab vedotin + R-CHP	R-CHOP
Grade 3–4 AEs	57.7%	57.5%
Serious AEs	34.0%	30.6%
Grade 5 AEs	3.0%	2.3%
AEs leading to dose reduction	9.2%	13.0%