BAVENCIO receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma

▴ BAVENCIO receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
This year US FDA has approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021.

The opinion was based on positive findings from the Phase III JAVELIN Bladder 100 trial, results of which were published in The New England Journal of Medicine in September. BAVENCIO is the only immunotherapy to significantly prolong overall survival (OS) in locally advanced or metastatic UC in the first-line setting in a Phase III trial.

“Patients living with locally advanced or metastatic urothelial carcinoma in Europe are in urgent need of more treatment options that have the potential to extend their lives,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “The overall survival results from JAVELIN Bladder100 show the potential benefits of a first-line maintenance approach with BAVENCIO as a significant advancement for patients with locally advanced or metastatic urothelial carcinoma.”

Bladder cancer is the tenth most common cancer worldwide. In Europe alone, nearly 200,000 people are diagnosed with bladder cancer each year and more than 60,000 patients die from the disease, despite available treatments. UC, which accounts for about 90% of all bladder cancers, becomes harder to treat as it advances, spreading through the layers of the bladder wall. For patients with advanced UC, the five-year survival rate is 5%.6 About 4% of bladder cancers are diagnosed at an advanced stage.7

“BAVENCIO is the only immunotherapy treatment to demonstrate in the first-line setting the ability to help patients with locally advanced or metastatic urothelial carcinoma live longer,” said Danny Bar-Zohar, M.D., Global Head of Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “Now with this positive opinion, we have come to a big step closer to being able to offer a new option that may shift the treatment paradigm for patients in Europe.”

In June 2020, the US Food and Drug Administration (FDA) approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. Additional regulatory applications have been submitted in Japan and other countries.

Tags : #Pfizer #LatestNewsonPfizer12thDec #LatestPharmaNews12thDec #EMDSerono #MerckKGaA #LatestTreatmentonBladderCancer12thDec #TheNewEnglandJournalofMedicine #USFDAApproaved

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-



Trending Now

Actor-Director Sathish Kaushik Died of a Heart Attack at the Age of 66March 09, 2023
Soleus Push-Ups: A Laziest Exercise to Lower Blood Sugar LevelsMarch 09, 2023
World Kidney Day 2023: Be Aware of Kidney DiseasesMarch 09, 2023
Sushmita Sen reveals about suffering from a severe heart attack recently and Addison's disease in 2014March 06, 2023
A significant increase in influenza A H3N2 patients that are accompanied by severe coughing and feverMarch 06, 2023
Is AIDS or HIV curable in Ayurveda?March 03, 2023
Artificial Sweetener Erythritol Raises the Possibility of Heart Attack.March 01, 2023
Difference between HIV and AIDS - When to give antiretroviral therapy?March 01, 2023
Zero Discrimination Day: Let's Raise the Voice Against DiscriminationMarch 01, 2023
International Women’s Day 2023 – Embrace EquityFebruary 28, 2023
Brain Tumors - Types, Symptoms and Risk FactorsFebruary 28, 2023
World Rare Disease Day: End Stigma Against Rare Diseases.February 28, 2023
National Science Day 2023 - Global Science for Global WellbeingFebruary 28, 2023
Eating disorders - Types and their complicationsFebruary 27, 2023
The condition that took away the life of Malayalam filmmaker, Joseph ManuFebruary 27, 2023
World NGO Day 2023 - We make a living by what we get, but we make a life by what we giveFebruary 27, 2023
Functions and Problems of SerotoninFebruary 25, 2023
Arthritis management – Tips to manage arthritis effectivelyFebruary 25, 2023
Apple has undertaken a project of no-prick blood sugar monitoring feature for its watch.February 24, 2023
Bird flu – Jharkhand on alert, know its prevention and symptoms in humansFebruary 24, 2023