Navigation Links
Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy
Date:6/24/2011

s approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing mCRC is based on PFS. More than half of patients who receive Vectibix monotherapy respond to treatment with an average six month PFS benefit.  Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.

Retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of mCRC with these mutations.(ix)

In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as a monotherapy for the treatment of patients with EGFR-expressing mCRC with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.(x)  Vectibix has been launched in more than 30 European countries, Russia, Israel, Australia, Canada and Japan. Applications in the rest of the world are pending.

Important U.S. Product Safety Information

WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS

Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

Infusion Reactions: Severe infusion reactions occurred in approximately one percent of patients. Fatal infusion reactions occurred in postmarketing experience [See Dosage and Administration (2.1), Warnings and P
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related biology technology :

1. Amgen Announces Webcast of 2008 Third Quarter Financial Results
2. Amgens Third Quarter 2008 Adjusted Earnings Per Share Increased 14 Percent to $1.23
3. Call for Applications: The Amgen Award for Science Teaching Excellence
4. Amgen to Webcast 2008 Business Review Meeting on November 7 From Millennium Hotel in New York
5. Amgen Positioned to Deliver Attractive Growth Over Next Five Years
6. Amgen Foundation Announces $2.5 Million Expansion of Amgen Scholars Program to Europe
7. Amgen to Present at the 27th Annual JP Morgan Healthcare Conference
8. Amgen Announces Webcast of 2008 Fourth Quarter and Full Year Financial Results
9. Amgens Breakaway from Cancer Initiative Expands to Help Cancer Patients Access Broad Spectrum of Cancer Resources and Services
10. Amgens Fourth Quarter 2008 Adjusted Earnings Per Share Increased 6 Percent to $1.06; Full Year 2008 Adjusted Earnings Per Share Increased 6 Percent to $4.55
11. FDA Accepts Amgens Submission and Files Biologics License Application for Denosumab
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Niagara Thermal Products is proud to announce that ... ("B3") as the critical thermal component supplier in support ... Corps of Engineers.  B3 has developed the only comprehensive ... destroys VOCs and other chemical pollutants, allergens and organic ...
(Date:1/15/2014)... RedBrick Health , a fast-growing leader in consumer health ... EmblemHealth , the New York -based ... RedBrick Compass health assessment, combined with the RedBrick Journeys ... EmblemHealth is among the first health plans in the ...
(Date:1/15/2014)... 15, 2014 Two champions of science, ... sponsorship of an annual competition for middle and high ... to, innovative STEM study. The competition presents students with ... of Engineering Aptitude, Mathematics, and Sciences is a ...
(Date:1/15/2014)... Freeslate, Inc ., the leading provider of ... one of India’s top five pharmaceutical companies, has received ... for high throughput solid form screening. , Lupin, ... range of quality, affordable generic and branded formulations and ...
Breaking Biology Technology:Niagara Thermal Products LLC Selected as Critical Supplier for Buffalo BioBlower Air Purification Systems 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 3
... Anne T. Ferguson, Ph.D., ... , INTRODUCTION , This application ... from Molecular Devices to study the performance of the LIVE/DEAD ... fluorescent dyes, calcein AM (cal AM) and ethidium homodimer (EthD-1), to ...
... , A Sensitive, Robust, Homogenous,and Rapid Assay , ... method , Assays a broad range of tyrosine kinases ... in a kit and in bulk packaging , , ... activity can be accelerated using High Efficiency Fluorescence Polarization ...
... David Handfield, Martin Boissonneault, Esther Tremblay, Benoit Houle and Luc Mnard. ... , Recent advances in ... in both the number of compounds and potential drug targets that ... assay systems has helped to meet the demand for increased throughput. ...
Cached Biology Technology:LIVE/DEAD Viability/Cytotoxicity Assay for Animal Cells Using the SpectraMax Gemini XS Fluorescence Microplate Reader (MaxLine Application Note #43) 2LIVE/DEAD Viability/Cytotoxicity Assay for Animal Cells Using the SpectraMax Gemini XS Fluorescence Microplate Reader (MaxLine Application Note #43) 3LIVE/DEAD Viability/Cytotoxicity Assay for Animal Cells Using the SpectraMax Gemini XS Fluorescence Microplate Reader (MaxLine Application Note #43) 4LIVE/DEAD Viability/Cytotoxicity Assay for Animal Cells Using the SpectraMax Gemini XS Fluorescence Microplate Reader (MaxLine Application Note #43) 5TKXtra DataFile: Homogenous tyrosine kinase detection using High Efficiency Fluorescence Polarization 2TKXtra DataFile: Homogenous tyrosine kinase detection using High Efficiency Fluorescence Polarization 3Development of Radioligand Binding Assays for the Motilin Receptor Using ScreenReady Targets. 2Development of Radioligand Binding Assays for the Motilin Receptor Using ScreenReady Targets. 3Development of Radioligand Binding Assays for the Motilin Receptor Using ScreenReady Targets. 4Development of Radioligand Binding Assays for the Motilin Receptor Using ScreenReady Targets. 5
(Date:4/17/2014)... RSV infection , Respiratory syncytial virus (RSV) ... infections, generating life-threating illness in very young and ... limited. RSV enters host cells through the fusion ... bundle. Small interfering peptides that prevent bundle formation ... are highly susceptible to degradation. In this issue ...
(Date:4/17/2014)... Professor Marc Andr Gauthier and Professor Luca Razzari ... each been awarded large grants from the John ... for Innovation (CFI) for the acquisition of state-of-the-art ... be added matching grants from the Ministre de ... et de la Technologie (MESRST). These new laboratories ...
(Date:4/17/2014)... cells in bone marrow need to produce hydrogen sulfide ... according to a new study from the Center for ... Dentistry of USC. , Professor Songtao Shi, principal investigator ... produced by the cells governs the flow of calcium ... signals that results in osteogenesis, or the creation of ...
Breaking Biology News(10 mins):JCI online ahead of print table of contents for April 17, 2014 2JCI online ahead of print table of contents for April 17, 2014 3JCI online ahead of print table of contents for April 17, 2014 4JCI online ahead of print table of contents for April 17, 2014 5JCI online ahead of print table of contents for April 17, 2014 6New state-of-the-art biotech and nanotech equipment for INRS 2
... is available in German . , Scientists of ... investigated another navigational skill of desert ants. These ants are ... sun compass along with a step counter and visible landmarks ... research team from Jena recently discovered that these ants also ...
... of Biological Sciences (AIBS) has selected Meredith Niles, a ... Richards, a graduate student at the University of Maryland, ... the University of Rhode Island, to receive the 2010 ... "AIBS is committed to fostering a productive dialogue between ...
... Americans recognize things need to change in the grocery ... is included in their food and on the packages. ... the right food choices to avoid obesity, but will readily ... new survey by FoodMinds. "In light of all the ...
Cached Biology News:Smelling the scenery in stereo 2AIBS names emerging public policy leaders 2AIBS names emerging public policy leaders 3Americans want Uncle Sam's help putting healthy foods on their dinner table 2
... Ascent FL is equipped ... luminometric measurement technologies that ... of advanced features of ... Ascent. Fluoroskan Ascent FL ...
...
...
... cabinets Heraeus HERAsafe KS convince with an optimum ... new frameless slanted window does not obscure the ... window design makes it easy to work in ... a height of more than 250 mm ensures ...
Biology Products: