The US Food and Drug Administration has approved pola-R-CHP for adults with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or high-grade B-cell lymphoma. The approval is for patients with an International Prognostic Index score of two or greater.
“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, Genentech Chief Medical Officer and head of Global Product Development, said in the announcement. “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 FDA decision converts the accelerated approval of polatuzumab vedotin in combination with bendamustine and rituximab for relapsed or refractory DLBCL after at least two prior therapies to regular approval, according to an announcement from Genentech.
The FDA approval of pola-R-CHP for first-line treatment of DLBCL is based on pivotal data from POLARIX, an international phase III, randomized, double-blind, placebo-controlled study that “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, compared to R-CHOP, according to the release.
The risk of disease progression, relapse, or death was reduced by 27% in patients who received pola-R-CHP (n=440) compared with those who received R-CHOP (n=439; hazard ratio [HR], 0.73; 95% CI, 0.57-0.95; P<.02). The safety profile of pola-R-CHP was “comparable” to that of R-CHOP, officials said in the release.
The approval follows the FDA Oncologic Drugs Advisory Committee vote of 11 to 2 in favor of pola-R-CHP for patients with previously untreated DLBCL.
The combination has been approved for adults with previously untreated DLBCL in more than 70 countries, officials said.
Source: Genentech, April 2023