Roche's Polivy Combination Receives EU Approval as First Treatment in Over Two Decades to Significantly Improve Progression-Free Survival in Untreated DLBCL
Roche
Oncology Drug Research, Development, and Manufacturing
European Union
The European Union (German: Europäische Union; French: Union européenne), abbreviated as the EU, is headquartered in Brussels, the capital of Belgium. It evolved from the European Communities and originally had six founding member states: Germany, France, Italy, the Netherlands, Belgium, and Luxembourg. The Union currently has 28 member states and 24 official languages.In December 1991, the European Council meeting in Maastricht adopted the Treaty on European Union, commonly known as the Maastricht Treaty. On November 1, 1993, the Maastricht Treaty officially entered into force, marking the formal establishment of the European Union. In 2012, the EU was awarded the Nobel Peace Prize.Donald Tusk serves as President of the European Council, and Antonio Tajani is President of the European Parliament. Jean-Claude Juncker, former Prime Minister of Luxembourg, is President of the European Commission.The EU’s treaties have been amended multiple times, and its operations are governed by the Treaty of Lisbon. Politically, all member states are democracies (according to The Economist’s 2008 Democracy Index). Economically, it constitutes the world’s second-largest economic entity (with Germany, France, and Italy being members of the G8). Militarily, the vast majority of EU member states are also members of the North Atlantic Treaty Organization (NATO).
Today, Roche announced that the European Union has approved the antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin) for use in combination with a regimen called R-CHP as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). The press release noted that this is the first treatment regimen in over 20 years to provide a clinically meaningful improvement in progression-free survival for this patient population.
DLBCL is the most common type of non-Hodgkin lymphoma, with approximately 150,000 people worldwide diagnosed with DLBCL each year. While first-line treatment is often effective, up to 40% of patients experience relapse or develop refractory disease, leaving them with limited treatment options, shorter survival times, and unmet medical needs.
Polivy specifically binds to CD79b on tumor cells, delivering anticancer drugs to kill these B cells while minimizing harm to normal cells. Polivy has been approved in more than 60 countries and regions worldwide for use in combination with bendamustine or rituximab (Rituxan) to treat patients with relapsed or refractory DLBCL.
This approval is based on the efficacy and safety data from a Phase 3 clinical trial. The trial results showed that the Polivy combination therapy reduced the risk of disease progression or death by 27% (HR=0.73; 95% CI: 0.57-0.95; P<0.0177) compared to the standard treatment of rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP). The results of this clinical trial have been published in The New England Journal of Medicine.
"After more than 20 years with limited treatment options, the approval of Polivy plus R-CHP combination marks a new era for patients with this aggressive disease," said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. "We are delighted that the EU has approved this Polivy regimen and believe it has the potential to significantly impact the lives of patients with DLBCL."
References:
[1] Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma. Retrieved May 25, 2022, from https://www.globenewswire.com/news-release/2022/05/25/2450608/0/en/Roche-s-Polivy-combination-approved-by-European-Commission-for-people-with-previously-untreated-diffuse-large-B-cell-lymphoma.html
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