FDA approves Polivy regimen for previously untreated diffuse large B-cell lymphoma
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The FDA approved polatuzumab vedotin-piiq in combination with rituximab, cyclophosphamide, doxorubicin and prednisone as first-line therapy for patients with certain types of B-cell lymphoma.
The approval applies to adults with previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma who have an International Prognostic Index score of two or greater.
Polatuzumab vedotin-piiq (Polivy, Genentech) — an antibody-drug conjugate — targets CD79b on the surface of malignant B cells. The FDA granted the agent accelerated approval in June 2019 for use in combination with bendamustine and rituximab (Rituxan; Genentech, Biogen) as treatment for relapsed or refractory DLBCL after at least two previous therapies. The FDA decision announced Wednesday converts that accelerated approval to a regular approval.
“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a Genentech press release. “Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option [that] may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”
FDA based the regular approval on results of the randomized phase 3 POLARIX trial, which evaluated polatuzumab vedotin-piiq plus R-CHP vs. the standard-of-care R-CHOP regimen (R-CHP plus vincristine).
The trial included 879 patients (mean age, 63.1 years; 53.8% male) with previously untreated large B-cell lymphoma. Researchers assigned 440 patients to polatuzumab vedotin-piiq plus R-CHP. The other 439 patients received R-CHOP.
Investigator-assessed PFS served as the primary endpoint. EFS for efficacy reasons, complete response rate assessed by PET/CT at end of treatment and OS served as key secondary endpoints.
The polatuzumab vedotin-piiq regimen conferred a 27% reduction in relative risk for disease progression, relapse or death compared with R-CHOP (HR = 0.73; 95% CI, 0.57-0.95), which met the primary endpoint. The regimens exhibited similar overall safety profiles.
Last month, FDA’s Oncologic Drugs Advisory Committee voted 11-2 in favor of the regimen’s risk-benefit profile as first-line treatment for patients with large B-cell lymphoma.
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