The US Food and Drug Administration (FDA) has approved Roche’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients.
The combination therapy is indicated to treat adult patients with DLBC not otherwise specified, or high-grade B-cell lymphoma, who also have an International Prognostic Index (IPI) score of at least two.
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It is claimed to be the first therapy in 20 years to receive approval in the US as a first-line treatment for DLBCL.
Roche chief medical officer and global product development head Levi Garraway stated: “It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma.
“Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”
The regulatory approval is based on the data obtained from a randomised, placebo-controlled, double-blind, international Phase III POLARIX trial.
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By GlobalDataThe trial assessed the pharmacokinetics, safety and efficacy of Polivy in combination with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) against MabThera/Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in previously untreated DLBCL patients.
The combination of Polivy and R-CHP reduced the risk of disease progression, relapse or death by 27% in comparison to R-CHOP.
The most common adverse events (AEs) in the trial were diarrhoea, alopecia, nausea, mucositis, peripheral neuropathy, constipation and fatigue, while lymphopenia and neutropenia were the most common grade 3-4 AEs observed.
The company expects the combination therapy to reduce the burden associated with disease progression on both patients and healthcare systems.
