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
Resolute Communications

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:

(Date:9/17/2019)... ... September 17, 2019 , ... Since the registration of the ... Act in the US, Nocimed has been marketing its unique technology to healthcare ... existing MRI equipment to perform MR spectroscopy, NociScan detects the presence of chemical ...
(Date:9/17/2019)... (PRWEB) , ... September 17, 2019 , ... ... and Dental Implants welcome patients with missing teeth in Chattanooga, TN for customized ... by a periodontist in as little as one day, providing a permanent tooth ...
(Date:9/17/2019)... , ... September 17, 2019 , ... Lubin Austermuehle, ... fundraiser. Gather for GRIN2B will be held at Found Kitchen and Social ... Proceeds will help fund research on GRIN2B-Related Neurodevelopmental Disorder, a rare condition that results ...
(Date:9/17/2019)... , ... September 17, 2019 , ... ... group BPAN Warriors , with the goal of providing resources to assist ... Protein-Associated Neurodegeneration (BPAN), a progressive disease causing abnormal iron deposits in the brain. ...
(Date:9/17/2019)... ... September 17, 2019 , ... ... October 18 "Pacifica Experience" Open House day on Pacifica's Lambert Campus, 249 ... programs in Depth Psychology, the Humanities, Clinical Psychology, Counseling Psychology, and Mythological ...
Breaking Medicine News(10 mins):
(Date:9/17/2019)... ... September 17, 2019 , ... Today, in partnership with ... contraception and consent with student and faculty from The City University of New ... Francisco Ramirez, MPH; Elise Schuster, MPH; Raffaele M. Bernardo, DO, FACP, AAHIVS and ...
(Date:9/17/2019)... ... September 17, 2019 , ... Embr Labs , the ... Series B funding led by DigiTx Partners, with participation from Safar Partners, ... use the investment to grow the company’s footprint in wellness and digital therapeutics, accelerate ...
(Date:9/17/2019)... ... September 17, 2019 , ... Gustavo Grodnitzky, PhD will join the ... Yoga Science as holistic mind/body medicine for physicians and other health care professionals. Entitled ... 22-26, 2019 at the Cranwell Resort and Spa in Lenox, Massachusetts, is accredited by ...
Breaking Medicine Technology:
Cached News: