EMA validates use of BAVENCIO for treating Urothelial Carcinoma
Category: #health  By Nikita Chaurasia  Date: 2020-06-24
  • share
  • Twitter
  • Facebook
  • LinkedIn

EMA validates use of BAVENCIO for treating Urothelial Carcinoma

German multinational pharmaceutical, chemical, and life sciences company, Merck KGaA, headquartered in Darmstadt, recently declared that the European Medicines Agency (EMA) has approved the review process for the Type II variation application for BAVENCIO ® (avelumab) for first-line treatment of patients suffering with locally advanced or metastatic urothelial carcinoma (UC), the most common form of bladder cancer.

Reportedly, results from the Phase III JAVELIN Bladder 100 study proved that BAVENCIO together with best supportive care (BSC) as a first-line maintenance treatment after induction chemotherapy showed considerable improvement in overall survival (OS) of the patients in comparison to standalone BSC.

If reports are to be believed, the supplemental Biologics License Application (sBLA) for first-line maintenance treatment of locally advanced or metastatic UC patients was given Priority Review status under the FDA’s Real-Time Oncology Review (RTOR) pilot program. BAVENCIO was also granted a Breakthrough Therapy Designation by the FDA for this indication.

Additionally, Japan's Ministry of Health, Labour and Welfare has also welcomed the supplemental new drug application for BAVENCIO as a first-line maintenance therapy for locally advanced or metastatic UC.

For the record, urothelial carcinoma accounts for 90% of bladder cancers. Besides this, about 200,000 individuals are diagnosed with bladder cancer each year in the European Union, which claims lives of more than 60,000 individuals annually. 

Previously, Merck’s Keytruda (pembrolizumab) drug combined with platinum-based chemo for untreated advanced UC didn’t prove effective for patients whose disease had spread to other body parts. Keytruda is already approved as a first-line treatment for UC patients who can’t endure cisplatin-based chemotherapy, but the failed results from the KEYNOTE-361 trail has prevented the drug’s enhanced use in these patients.

Although Keytruda couldn’t pass the trails, Merck’s BAVENCIO has exhibited potential in reducing the increasing burden of UC.

Source: https://www.pfizer.com/news/press-release/press-release-detail/european-medicines-agency-validates-application-bavencior

https://www.pmlive.com/pharma_news/failed_trial_dashes_mercks_hopes_for_keytruda_in_first-line_bladder_cancer_1341996

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Nikita Chaurasia    

Nikita Chaurasia

Having always been daft at wordplay, Nikita Chaurasia, post the completion of post-graduation, commenced her journey into the content generation cosmos. Endowed with a professional MBA degree in Advertising and Public Relations, Nikita strives to integrate her creativ...

Read More

More News By Nikita Chaurasia

New research claims sufficiency of vitamin D reduces COVID-19 severity
New research claims sufficiency of vitamin D reduces COVID-19 severity
By Nikita Chaurasia

According to a recent study, COVID-19 patients having sufficient levels of vitamin D, with at least 30 ng/mL of 25-hydroxyvitamin D in their blood, are less likely to witness severe clinical outcomes and deaths. The study, which was published by the...

Amazon adds indoor surveillance drone to security solutions portfolio
Amazon adds indoor surveillance drone to security solutions portfolio
By Nikita Chaurasia

  This is the next big launch after the announcement of car security devices Indoor drone will offer video surveillance in places devoid of static cameras U.S.-based multinational technology giant, Amazon.com Inc. along with Ring Inc. has ...

JPMorgan to move USD 234 billion worth assets to Germany before Brexit
JPMorgan to move USD 234 billion worth assets to Germany before Brexit
By Nikita Chaurasia

  JPMorgan indicated plans to expand its hub in Paris by reassigning services based in London post Brexit The bank plans on completing the migration of its assets to the Frankfurt subsidiary by the end of 2020 As per reliable sources, Amer...