FDA Approves Polivy Regimen for DLBCL


The Food and Drug Administration approved Polivy plus Rituxan, cyclophosphamide, doxorubicin and prednisone for patients with previously untreated diffuse large B-cell lymphoma — marking the first new regimen in nearly two decades for this patient population.

The Food and Drug Administration (FDA) approved Polivy (polatuzumabvedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone —a four-drug combination known as R-CHP — for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to Genentech, the manufacturer of Polivy. 

“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” said Dr. Levi Garraway, chief medical officer and head of global product development, in a press release from the company. “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 works by inhibiting CD79b, a protein found on B cells that can play a role in the growth and proliferation of cancer.

The approval is based on findings from the phase 3 POLARIX clinical trial, which included 879 adult patients and compared Polivy plus R-CHP to the current standard of care for this patient population, Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).

Study findings showed that at an average follow-up of 28.2 months, there was a 27% reduction in the risk of disease production or death for patients given the Polivy-containing regimen compared to those given standard of care. Also, at the two-year mark, event-free survival (time a patient lives without complications or worsening of their cancer) was 75.6% in the Polivy group, compared to 69.4% in the standard-of-care group.

Of note, there was not a significant difference in the percentage of patients who experienced a complete response — meaning that their disease completely disappeared — between the two treatment groups. There was also no difference in the average time patients lived after being treated (a statistic known as overall survival).

The side effect profile was also similar between the two treatment groups, with moderate to severe side effects occurring in 57.7% and 57.5% in the Polivy-containing and standard-of-care groups, respectively. Side effects that led to a dose reduction occurred in 9.2% of patients given Polivy and 13% of patients given the standard of care.

The most common side effects from the Polivyregimen were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, hair loss and mucositis (mouth sores). The most common moderate to severe side effects were lymphopenia and neutropenia.

Three percent of patients experienced a fatal side effect in the Polivy group compared to 2.3% of patients administered standard of care.

In a March 9 meeting of the Oncologic Drugs Advisory Committee, which evaluates the safety and efficacy of cancer drugs, a group of experts voted in favor that the risks outweigh the benefits of the Polivy-containing regimen.

“POLARIX is a positive study and met its primary endpoint of progression-free survival. A more durable progression-free survival was observed with (Polivy plus R-CHP) and had a higher proportion of patients without disease progression at two years,” said Jamie Hirata, global development leader ofPolivyat Genentech, during the meeting.

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