Navigation Links
Amgen to Appeal CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer in Europe
Date:3/30/2011

THOUSAND OAKS, Calif., March 30, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) announced today that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in March by the Committee For Medicinal Products for Human Use (CHMP) for the use of Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Amgen believes that Vectibix in combination with chemotherapy provides an important treatment option for patients with wild-type KRAS mCRC.  Amgen remains committed to patients with this aggressive disease, for whom there are limited treatment options.

Data from studies 20050203 (PRIME) and 20050181 ('181') showed that adding Vectibix to FOLFOX and FOLFIRI chemotherapy, respectively, improved progression-free survival (PFS) versus chemotherapy alone in patients with wild-type KRAS mCRC.  Patients taking this combination have a greater chance of living longer without their disease getting worse.  Additionally, the response rate of Vectibix plus chemotherapy was higher than chemotherapy alone.  Though quantitatively greater, the improvement in median overall survival did not achieve statistical significance in the Vectibix arm of either trial.(i)(ii)

In general, adverse event rates were comparable across arms in both studies, with the exception of known toxicities associated with anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients. In patients with mutant KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone.(iii)(iv)

Vectibix is already approved and established in more than 30 countries outside of the United States (U.S.) as a monotherapy treatment for
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Amgen Donates $1 Million to Help Japanese Disaster Victims
2. Amgen Completes Acquisition of BioVex
3. NBPTS and Amgen Foundation Join to Bolster Science Education
4. Amgen to Present at the Citi 2011 Global Healthcare Conference
5. CURE Magazine Teams Up With Amgen Oncology and Breakaway from Cancer® to Launch 2011 Extraordinary Healer Award for Oncology Nursing
6. Boehringer Ingelheim to Purchase Amgens Fremont (USA) Facility
7. Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21
8. Genelux Corporation Expands Board of Directors, Appointing Dennis Fenton, Former Amgen Executive
9. Boehringer Ingelheim to Purchase Amgens Fremont (California) Facility
10. MedImmune In-Licenses Clinical-Stage Anti-Inflammatory Monoclonal Antibody From Amgen
11. Amgen to Present at the 29th Annual JP Morgan Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... 2014   Mary,s Medicinals today announced that ... 4-Star Sponsor of Operation Grow4Vets , a national, ... programs and services to assist them in living with ... Facts: , An ever-increasing number of medical ... effective treatment for pain, Post-traumatic Stress Disorder (PTSD) and ...
(Date:10/19/2014)... MELVILLE, N.Y. , Oct. 19, 2014  Henry ... largest provider of health care products and services to ... that it has invested in Iwase Dental Supply, Inc., ... equipment in Japan.  The transaction marks Henry Schein,s entrance into ... largest dental market, and increases to 28 the ...
(Date:10/17/2014)... -- Hanger, Inc. (NYSE: HGR ) announced today ... for the quarter ended September 30, 2014, on Thursday, ... call to discuss these results is scheduled to begin ... Those wishing to participate should call 1-877-662-6095. A replay ... dialing 1-855-859-2056 and referencing Conference ID # 91880739. ...
Breaking Medicine Technology:Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 2Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 3Henry Schein Enters Japan With Investment in Iwase Dental Supply 2Henry Schein Enters Japan With Investment in Iwase Dental Supply 3Henry Schein Enters Japan With Investment in Iwase Dental Supply 4Henry Schein Enters Japan With Investment in Iwase Dental Supply 5
... AMGN ) reported adjusted earnings per share (EPS) of ... percent compared to $1.05 for the fourth quarter of 2009.  Adjusted ... quarter of 2010 compared to $1,065 million in the fourth quarter ... versus $4.91 in 2009, a 6 percent increase.  Full year 2010 ...
... Athersys, Inc. (Nasdaq: ATHX ), a ... January 11th Retail Investor Conferences.com presentation is available ... and Chief Executive Officer of Athersys, presented to ... To view the archived presentation, click ...
Cached Medicine Technology:Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 2Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 3Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 4Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 5Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 6Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 7Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 8Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 9Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 10Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 11Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 12Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 13Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 14Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 15Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 16Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 17Amgen’s Fourth Quarter 2010 Adjusted Earnings Per Share Increased 11 Percent to $1.17; Full Year 2010 Adjusted Earnings Per Share Increased 6 Percent to $5.21 18Athersys, Inc. - Retail Investor Conferences.com Presentation Now Available Online 2
(Date:10/20/2014)... National Teen Driver Safety Week is October 19-25, ... Pediatrics (Ohio AAP, http://www.ohioaap.org ) is joining the National ... drivers to talk to their teens and always set the ... are the leading cause of death for U.S. teens. In ... and 859 (42%) of those teen drivers were killed in ...
(Date:10/20/2014)... New York, NY (PRWEB) October 20, 2014 ... to be introduced in the U.S., has a lot to ... time when our country recognizes the achievements and contributions of ... marks the anniversary for Punzoné, and today it shares its ... and take a trip to Italy - even if it ...
(Date:10/19/2014)... (PRWEB) October 20, 2014 The ... iPage ( http://www.top10bestseohosting.com/go/iPage/ ) and GreenGeeks are the ... excellent platforms for those who want to buy ... same time. , The IT manager of Top10BestSEOHosting.com ... the most recommended suppliers for everyone. A lot ...
(Date:10/19/2014)... 20, 2014 Having been working in the ... knowledge of customer needs. According to James, one of the ... dazzling sequins, or with high-low skirts that add beauty to ... demand. Recently, LunaDress has unveiled its new selection of 2014 ... the company’s brand new items are available in over 20 ...
(Date:10/19/2014)... Visual Impact Frequency Training - a ... to the public generating a frenzied buzz of ... community. The commotion surrounding the program's launch has ... an investigative review. , "Many gym-goers are familiar ... known as a training 'plateau' where they are ...
Breaking Medicine News(10 mins):Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4Health News:Top10BestSEOHosting.com Considers iPage And GreenGeeks As The Best Dedicated Server Hosting Suppliers 2Health News:2014 Long Prom Dresses From LunaDress Now Available In Over 20 Popular Designs 2Health News:Visual Impact Frequency Training Review: Rusty Moore's Latest Fitness Guide Released 2
... - Quarter Highlighted by Regulatory Approval of Once-Daily Tramadol in, ... for Novel Treatment for Depression -,LAVAL, QC, Feb. 26 /PRNewswire-FirstCall/ ... today reported its results for the fourth quarter and year ... unless otherwise stated. , "With our first product about to ...
... To Autism" and Provides Important Information on Early ... Toys"R"Us and Babies"R"Us stores nationwide will kick off ... Speaks, the nation,s leading organization dedicated to increasing ... the causes, prevention and treatments for autism; and ...
... Velos, Inc., the recognized leader and trusted ... Net.Orange, Inc., the respected healthcare Internet solutions company, ... Research Centers (Mary Crowley). The two companies have ... strong central clinical research infrastructure and implementation of ...
... Originals2 Footwear by BeechHUNTINGTON BEACH, Calif., Feb. 26 ... Sandals(R) Originals line with new adjustable toe ... patented foot therapy can now be customized to ... , increasing flexibility and helping improve balance and ...
... ( http://www.GlenwoodSystems.com ) launches the GlaceComplete product suite which seamlessly integrates ... assisted medical billing process. The product has been designed to ... revenue contribution for the average office based medical practice. , ... ...
... AmeriGlide Achiever Scholarship. This scholarship is available to full time college ... ... (PRWEB) February 26, 2009 -- AmeriGlide Stair Lifts announced ... AmeriGlide Achiever Scholarship is available to full time college students who ...
Cached Medicine News:Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 2Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 3Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 4Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 5Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 6Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 7Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 8Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 9Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 10Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 11Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 12Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 13Health News:Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008 14Health News:Toys'R'Us and Babies'R'Us Launch In-Store Fundraising Campaign to Benefit Autism Speaks 2Health News:Toys'R'Us and Babies'R'Us Launch In-Store Fundraising Campaign to Benefit Autism Speaks 3Health News:Mary Crowley Cancer Research Centers Achieve Dramatic Improvements in Financial Infrastructures With Velos eResearch and Net.Orange Systems 2Health News:Mary Crowley Cancer Research Centers Achieve Dramatic Improvements in Financial Infrastructures With Velos eResearch and Net.Orange Systems 3Health News:Mary Crowley Cancer Research Centers Achieve Dramatic Improvements in Financial Infrastructures With Velos eResearch and Net.Orange Systems 4Health News:Sandal Evolution(R) Takes a Healthy Step 2Health News:Glenwood Systems, LLC Improves Medical Billing Process with GlaceComplete 2Health News:Glenwood Systems, LLC Improves Medical Billing Process with GlaceComplete 3Health News:AmeriGlide Announces Recipient of AmeriGlide Achiever Scholarship 2
Indications For Usage: ,Pediatric (recommended tidal volume 70-250ml), single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intend...
... Thermovent® T helps provide protection to the exposed ... and extremely lightweight making it ideal for active ... high rate of heat and moisture recovery, it ... ,All HMEs and filters have ISO standard tapered ...
... Since 1991 Intersurgical Incorporated ... filters, heat and moisture ... therapy products, hand-held nebulizers ... of accessories and connectors ...
... Intersurgical Incorporated manufactures high ... and moisture exchangers, ventilator ... hand-held nebulizers and an ... and connectors for anesthesia ...
Medicine Products: