Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) is indicated for the treatment of adults previously untreated DLBCL, or high-grade B-cell lymphoma (HGBL)
Genentech headquarters in South San Francisco, California, US. (Credit: Coolcaesar/Wikipedia)
Roche’s subsidiary Genentech has received the US Food and Drug Administration (FDA) approval for Polivy combination to treat a type of diffuse large B-cell lymphoma (DLBCL).
The US health agency approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP).
The combination is indicated for adults with previously untreated DLBCL, or high-grade B-cell lymphoma (HGBL) and with an International Prognostic Index (IPI) score of two or above.
The FDA approval follows the regulator’s Oncologic Drugs Advisory Committee (ODAC) vote in favour of Polivy plus R-CHP for previously untreated DLBCL.
It converts the accelerated approval granted for Polivy plus bendamustine and Rituxan for the treatment of relapsed or refractory (R/R) DLBCL, into regular approval.
Polivy combination for previously untreated DLBCL has been approved in more than 70 countries, including in the EU, the UK, Japan, Canada and China, said the biotechnology company.
Genentech chief medical officer and global product development head Levi Garraway said: “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.”
Polivy is an antibody-drug conjugate (ADC) that targets CD79b, a protein expressed specifically and predominantly in B cells, through the delivery of an anti-cancer agent.
Genentech is developing the drug using Seagen’s ADC technology and is currently being investigated for the treatment of several types of NHL.
The FDA approval of Polivy plus R-CHP is based on data from the Phase 3 POLARIX clinical trial,
In the randomised, double-blind, placebo-controlled study, treatment using Polivy plus R-CHP showed statistically significant and clinically meaningful improvement compared to R-CHOP.
The combination treatment also reduced the risk of disease progression, relapse, or death, by 27% when compared to R-CHOP alone.
Polivy plus R-CHP showed a comparable safety profile, with the most common AEs including peripheral neuropathy, nausea, fatigue, diarrhoea, constipation, alopecia, and mucositis.