Navigation Links
Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting
Date:12/16/2008

Society of Medical Oncology in 2008 from over 700 patients (including subjects randomized to Vectibix in "408") will be presented to the Committee for their consideration.

Data that KRAS is a clinically relevant biomarker for Vectibix is confined to the monotherapy setting; there is not yet sufficient data with Vectibix in combination with chemotherapy to conclude that KRAS is a valid predictive biomarker in that setting. However, pivotal studies "181" and "PRIME ("203") will be the first prospective Phase 3 clinical studies to test the effect of Vectibix in wild-type KRAS tumors in combination with chemotherapy and to determine the clinical utility of KRAS as a predictive biomarker in mCRC. Data from these trials will be available in 2009.

"Based on available data, we believe that focusing Vectibix treatment on patients with wild-type KRAS tumors will avoid unnecessary adverse events in patients who are unlikely to benefit, maximize response rates and PFS in patients with wild-type KRAS genes, and redirect patients with a mutated KRAS gene to alternative therapies," said Sean Harper. "We are thrilled to be taking a step forward in advancing the field of personalized medicine by being one of the first to realize the clinical potential of the KRAS gene in guiding treatment of advanced colorectal cancer patients."

In November, the National Comprehensive Cancer Network (NCCN) announced updates to their Guidelines on Colon and Rectal Cancers that included the recommendation that a determination of the KRAS gene status of either the primary tumor or a site of metastasis should be part of the pre-treatment work-up for patients diagnosed with metastatic colorectal cancer. Further, the guidelines recommended that EGFr inhibitors, including Vectibix, should only be used in patients with tumors characterized by the wild-type KRAS gene.


'/>"/>
SOURCE Amgen
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. Six UK Hospitals Join Together in Using Varian Medical Oncology Information Network
2. Genstruct CEO, Dr. Keith Elliston, Invited to Speak at Oncology Clinical Trial Summit
3. Founder of ILEX Oncology and Triton Biosciences, Richard Love, Joins Board of Directors of Cell Therapeutics, Inc. (CTI)
4. Ranbaxy to Consolidate Position in Biopharmaceuticals and Speciality Injectables Including Oncology
5. Pharsight Invited to Present on Oncology Modeling and Simulation at Quantitative Pharmacology Symposium in China
6. PRA International to Present Audioconference on Oncology Research - Nov. 8
7. IMPAC Medical Systems to Offer Revenue Cycle Inc.s Array of Oncology Products and Services to Customers
8. AG Mednet to Provide Image Network for Southwest Oncology Group
9. Quest PharmaTech to Receive $3,000,000 to Develop Oncology Products Based on its SonoLight Technology
10. Center for Molecular Medicine Selected to Provide DNA Analysis for Childrens Oncology Group Leukemia Study
11. Oncology Metrics and Cureline Announce Joint Marketing Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... FALLS, N.Y., Jan. 15, 2014   Niagara Thermal Products ... by Buffalo BioBlower Technologies LLC ("B3") as the critical ... 2 award from the Army Corps of Engineers.  B3 ... kills all biological contaminants and destroys VOCs and other ...
(Date:1/15/2014)... MINNEAPOLIS , Jan. 15, 2014 ­ RedBrick ... and behavior change technology, today announces that EmblemHealth ... insurer and wellness company, is now providing the RedBrick ... digital coaching program, to all of its members. EmblemHealth ...
(Date:1/15/2014)... January 15, 2014 Two champions of ... their sponsorship of an annual competition for middle and ... access to, innovative STEM study. The competition presents students ... Tests of Engineering Aptitude, Mathematics, and Sciences is ...
(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
... Inc. announced the presentation of new data at the ... in Miami, Florida. The presentation was entitled "DAS181 ... Anti-inflammatory Effects in Animal Models of Asthma". , DAS181 ... drug candidate being studied in human clinical development for ...
... LONDON, November 9 Following ... Food and Drug Administration (FDA), privately,owned UK company Daval ... innovative,anti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drug,designation for ... ALS, also known as Lou Gehrig,s ...
... Biosystems Inc. (the "Company") announces today that it has ... William Gastle, the Chief Executive Officer and James Long, ... 12, 2009 in connection with the annual audited financial ... The Company initially filed the annual financial statements for ...
Cached Biology Technology:NexBio(R) Presents Data Showing Anti-Asthma Activity of DAS181 (Fludase(R)*) at ACAAI 2009 2NexBio(R) Presents Data Showing Anti-Asthma Activity of DAS181 (Fludase(R)*) at ACAAI 2009 3
(Date:4/17/2014)... COLUMBIA, Mo. April 17 In the most densely ... States, forests reflect two centuries of human needs, values ... logging and clearing forests for agriculture and development, have ... today, a U.S. Forest Service study reports. , The ... forest conditions and management needs in the Northern United ...
(Date:4/17/2014)... , Respiratory syncytial virus (RSV) is a ... life-threating illness in very young and elderly populations. ... enters host cells through the fusion protein RSV ... interfering peptides that prevent bundle formation limit RSV ... susceptible to degradation. In this issue of the ...
(Date:4/17/2014)... development of stem cell therapies to cure a variety ... cell populations based on cell surface markers. Researchers from ... that is highly expressed in a type of stem ... describe in an article in BioResearch Open Access ... publishers. The article is available free on the ...
Breaking Biology News(10 mins):Five anthropogenic factors that will radically alter northern forests in 50 years 2Five anthropogenic factors that will radically alter northern forests in 50 years 3JCI 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 6
... a goal the quickest way there" If the name ... the Weizmann Institute of Science, the pace might speed ... Nadav Kashtan, Elad Noor and Prof. Uri Alon of ... Systems Departments create computer simulations that mimic natural evolution, ...
... time ever discovered DNA from living bacteria that are more ... of still living organisms that old been found. The exceptional ... of cells and might even cast light on the question ... the current issue of PNAS (Proceedings of The National Academy ...
... Findings released today by the Health Department shed new light ... among workers who responded to the World Trade Center disaster ... Trade Center Health Registry, show that 3.6% of the 25,000 ... asthma after working at the site. That rate is 12 ...
Cached Biology News:Switching goals 2The world's oldest bacteria 2Survey finds elevated rates of new asthma among WTC rescue and recovery workers 2Survey finds elevated rates of new asthma among WTC rescue and recovery workers 3
...
... eBioscience Intracellular (IC) Fixation Buffer, ... Buffer (Cat. No. 00-8333), can be ... prior to performing intracellular staining of ... antigens. These solutions have been specially ...
... to JMJD2D ( Abpromise for all ... Synthetic peptide conjugated to KLH derived from ... JMJD2D.(Note: the amino acid sequence is proprietary)(Peptide ... Entrez Gene ID: 55693 ...
Cytofix/Cytoperm Kit 250 Tests...
Biology Products: