HOME >> MEDICINE >> NEWS
Roche files marketing application for Avastin with European health authorities

Roche today announced the submission of a Marketing Authorisation application to the European Union for Avastin (bevacizumab, rhuMAb-VEGF) as a treatment for first-line metastatic colorectal cancer in combination with chemotherapy. The application is based on data from a pivotal clinical study of over 900 patients on Avastin who experienced improved survival benefit compared to chemotherapy treatment alone. A safety database of more than 1,000 patients who received Avastin in clinical trials is also supporting the submission.

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die, and it is the most common cancer in developed countries.1

"We are delighted to announce the submission for marketing authorisation of Avastin in the European Union," said William M. Burns, Head of Roche Pharmaceuticals Division. "Roche is dedicated to the development of safe and efficacious treatments for many types of cancers, and we will work closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first treatment of its kind."

An application for approval of Avastin in metastatic colorectal cancer was filed with the US FDA in September and has been designated for priority review status.

Results of the pivotal study of Avastin in advanced colorectal cancer were announced earlier this year and demonstrated that Avastin plus a form of chemotherapy, the IFL regime, (5-FU/Leucovorin/CPT-11) improved median survival by approximately five months, compared to patients treated with IFL regime alone (20.3 months vs. 15.6 months).

Avastin is the first anti-cancer agent with proven efficacy in inhibiting vascular endothelial growth factor (VEGF), which suppresses tumour growth and the spread of cancer from one part of the body to another (metastasis).
'"/>

Contact: Elizabeth Park, Resolute Communications
elizabeth.park@resolutecommunications.com
44-207-357-8187
Resolute Communications
5-Dec-2003


Page: 1 2 3

Related medicine news :

1. Rochester, BCM test bird-flu vaccine in humans
2. Rochester chosen to focus on rare neurological diseases
3. Roche pledges continued support for Organ Transplantation Research Foundation
4. New rapid anthrax test developed through collaboration between Mayo Clinic and Roche Diagnostics. Test, which provides results in less than one hour, will be made available to United States laboratories
5. University of Rochester awarded patent for class of drugs known as cox-2 inhibitors
6. NYU/U. Rochester team find neurons in visual cortex adapt to images within .5 seconds of viewing
7. Research study profiles indoor tanners
8. Comprehensive gene profiles hold promise for improving outcome of pediatric leukemia
9. Diabetic women on hormone replacement therapy have better glycemic and lipid profiles
10. Gene expression profiles predict survival of lymphoma patients after chemotherpy
11. Profiles of myocardial infarction among South Asian Canadians

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2019)... ... , ... Kind LED is excited to announce that Kind LED Grow Lights ... is a complete premium grow tent setup designed for new growers to try their ... premium grow room at an affordable price, enabling first-time growers to purchase a complete ...
(Date:6/25/2019)... ... 25, 2019 , ... IDx, a privately held artificial intelligence ... Terminology (CPT) Editorial Panel has accepted a new category 1 CPT® code for ... Academy of Ophthalmology (AAO) with the support of IDx, facilitates correct billing of ...
(Date:6/25/2019)... ... June 25, 2019 , ... CrossCountry Consulting, a leading ... company’s Intelligent Automation and Data Analytics leadership team. In this role, Steve will ... across a range of industries, including financial services, healthcare, professional services, and technology, ...
(Date:6/24/2019)... ... 2019 , ... ASRC Federal Data Network Technologies has been ... contract. Awarded under the NITAAC CIO-SP3 Small Business GWAC, the task order has ... $90 million. , The Data Network Technologies team will provide systems integration and ...
(Date:6/20/2019)... CITY, Okla. (PRWEB) , ... June 20, 2019 ... ... is pleased to announce their partnership with Physical Therapy Solutions in Lawton, which ... Suite C, the clinic is the group’s 28th clinic in the state. ...
Breaking Medicine News(10 mins):
(Date:6/24/2019)... (PRWEB) , ... June 24, 2019 , ... ... of labs worldwide currently use a laboratory information management system, or LIMS. , ... two years. This is according to a new report, " The 2019 Market ...
(Date:6/24/2019)... Ill. (PRWEB) , ... June 24, 2019 , ... ... personal protective equipment designed to provide breathability and comfort for the electrical industry ... their commitment to worker safety. , The guide, titled Developing a Culture ...
(Date:6/20/2019)... ... ... Phlexglobal today announced an important industry advisory around the new European Medicines Agency ... and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best ... going into specific detail – unusual for most guidance documents – the new TMF ...
Breaking Medicine Technology:
Cached News: