(News Bulletin 247) – Roche announces that the US Food and Drug Administration (FDA) has approved Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma.
FDA approval of Polivy plus R-CHP for the first-line treatment of DLBCL is based on pivotal data from POLARIX, an international Phase III, randomized, double-blind, placebo-controlled study that demonstrated improvement statistically significant and clinically significant PFS versus R-CHOP.
DLBCL is an aggressive and difficult to treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States. About 31,000 people in the United States are expected to be diagnosed with DLBCL in 2023.
“Today’s decision by the FDA to approve Polivy in combination with R-CHP in this setting provides a much-needed new treatment option that may improve outcomes and bring other benefits to many patients with this condition. aggressive lymphoma.’ said Levi Garraway, MD, Ph.D., Roche’s chief medical officer and head of global product development.
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