Navigation Links
Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)
Date:7/17/2009

THOUSAND OAKS, Calif., July 17 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix((R)) (panitumumab). This decision follows the FDA's December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed.

"We are pleased that the FDA has recognized the clinical importance of KRAS as a predictive biomarker for anti-EGFr antibody therapy," said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen.

The INDICATION AND USAGE section of the prescribing information has been updated to include that retrospective subset analyses of metastatic colorectal cancer 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 colorectal cancer with these mutations.

The CLINICAL STUDIES section of the prescribing information has been updated to reflect results from retrospective analyses across seven randomized clinical trials with agents in this class. This includes the first Phase 3 analysis that showed mCRC patients with mutated KRAS tumors do not respond to monotherapy with an EGFr-inhibiting antibody (the Vectibix "408" trial).

"With this label update, physicians can now eliminate anti-EGFr antibodies as a treatment option for patients with mutated KRAS tumors and redirect those patients to alternative therapi
'/>"/>

SOURCE Amgen
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine news :

1. Amgen Appoints Rebecca M. Henderson to the Companys Board of Directors
2. 34 Outstanding Teachers and Schools Receive $10,000 Amgen Award for Science Teaching Excellence
3. AUDIO from Medialink and Amgen: Experts Agree Infection in Cancer Patients Impacts Treatment Success
4. Amgen to Present at the Goldman Sachs Global Healthcare Conference
5. Loyola fellow receives Amgen grant to study treatments for older leukemia patients
6. Amgens Denosumab and Eli Lillys Forteo/Forsteo Will Drive Robust Annual Growth in the Osteoporosis Drug Market From 2013 to 2018
7. Amgen Highlights Data to Be Presented at ASCO
8. Amgen to Present at the Deutsche Bank 34th Annual Healthcare Conference
9. Amgen and ONSEdge Partner With Cancer Survivor Jan Ping for New Campaign
10. Amgens First Quarter 2009 Adjusted Earnings Per Share Decreased 4 Percent to $1.08
11. Amgen Announces Webcast of 2009 First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/24/2014)... 2014 Volpara Solutions announced today ... the 100th Annual Meeting of the Radiology Society ... (RSNA Booth 1752 – South Hall). Volpara Solutions ... the rest of its innovative suite of quantitative ... enable personalized measurements of volumetric density, patient-specific dose, ...
(Date:11/24/2014)... SweetDressy.com, a well-known dress supplier and leader in the ... Dresses. All these fresh items are offered at affordable ... special offer is valid until Dec. 20, 2014. Click ... working well in the fashion industry for years. They ... dresses may be the best products for many ladies ...
(Date:11/24/2014)... SafeHandles™ announced that they will be featured in ... airing via Discovery Channel. Dates and show times TBA. ... replaceable, and affordable germ protective device. This segment will ... adhesives to promote hand hygiene in high traffic and ... is the desire to make a positive impact in ...
(Date:11/23/2014)... The clinical trial report, "Aspergillosis Global ... the Aspergillosis clinical trial scenario. This report provides ... trials on Aspergillosis. It includes an overview of ... per the site of trial conduction across the ... disease clinical trials by their phase, trial status, ...
(Date:11/23/2014)... Pro Ace Care, a renowned Vancouver hot water ... providing an 8 year warranty on its selected hot water ... up due to the impending winter season, it was important ... premium service that the company provides. As a result, Pro ... Wood and Bradford hot water tanks. , “Every installer ...
Breaking Medicine News(10 mins):Health News:Volpara Solutions to Launch VolparaAnalytics 1.2 at RSNA 2Health News:Volpara Solutions to Launch VolparaAnalytics 1.2 at RSNA 3Health News:SweetDressy.com Unveiled A New Selection Of Evening Dresses 2Health News:New Episode of Innovations TV Series to Feature SafeHandles™ 2Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 2Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 3Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 4Health News:Pro Ace Care Now Gives 8 Year Guarantee on Selected Vancouver Hot Water Tanks 2
... Paramount Acquisition,Corp. (OTC Bulletin Board: PMQC, PMQCU, ... the filing of a third,amendment to the preliminary ... that was originally filed on June 18, 2007. ... meeting of,stockholders to be held to consider the ...
... Rendell,recently appointed Richard Snyder, M.D., senior vice president ... the state,s Chronic Care,Commission. Snyder took his oath ... other commission appointees during its first meeting. ... for Pennsylvanians,living with chronic health conditions such as ...
... Barcelona, Spain: One of the largest individual studies of the ... concluded that it makes no difference whether a woman drinks ... itself (ethyl alcohol) and the quantity consumed that is likely ... risk from drinking three or more alcoholic drinks a day ...
... A new study adds fuel to the debate over whether ... cancer. , The study, presented by Australian ... in Barcelona, found some evidence suggesting exercise might increase the ... study included 24,479 Australian women aged between 27 and 75, ...
... 27 Sagent Pharmaceuticals,Inc., a privately-held specialty ... $53 million Series A financing led by ... used primarily to fund near-term product,launches, product ... development, sales and marketing,manufacturing and distribution partnerships. ...
... Pa., Sept. 26 Kensey Nash Corporation,(Nasdaq: ... Ramius Capital Group,L.L.C. and its affiliates on August ... the,Company,s outstanding common stock, as reported by Ramius ... Control" under the Company,s equity,compensation plan. As a ...
Cached Medicine News:Health News:Paramount Acquisition Corp. Files Amendment to Preliminary Proxy Statement for Proposed Acquisition of Chem Rx 2Health News:Paramount Acquisition Corp. Files Amendment to Preliminary Proxy Statement for Proposed Acquisition of Chem Rx 3Health News:Paramount Acquisition Corp. Files Amendment to Preliminary Proxy Statement for Proposed Acquisition of Chem Rx 4Health News:Governor Rendell Appoints Dr. Richard Snyder of Independence Blue Cross to Chronic Care Commission 2Health News:Governor Rendell Appoints Dr. Richard Snyder of Independence Blue Cross to Chronic Care Commission 3Health News:Wine, women and... spirits, beer and breast cancer risk 2Health News:Wine, women and... spirits, beer and breast cancer risk 3Health News:Study fuels debate over whether exercise and body size influence ovarian cancer risk 2Health News:Study fuels debate over whether exercise and body size influence ovarian cancer risk 3Health News:Sagent Pharmaceuticals Inc. Completes $53 Million Series A Financing 2Health News:Kensey Nash Reports Acceleration of Stock Awards Triggered by Shareholder Acquisition of Greater Than 20% of Outstanding Shares 2Health News:Kensey Nash Reports Acceleration of Stock Awards Triggered by Shareholder Acquisition of Greater Than 20% of Outstanding Shares 3Health News:Kensey Nash Reports Acceleration of Stock Awards Triggered by Shareholder Acquisition of Greater Than 20% of Outstanding Shares 4
(Date:11/21/2014)... Texas , Nov. 21, 2014  World Hemp ... containing low THC, announces they are now offering legal, ... to Charlotte,s Web type strains grown in medical marijuana ... other neurological disorders, such as Parkinson,s, MS, and spinal ... US laws to pass, because imported CBD Oil Is ...
(Date:11/21/2014)... 2014  Abaxis, Inc. (NasdaqGS: ABAX ), ... for the medical, research, and veterinary markets worldwide and ... markets in the United States , ... to acquire 100% of QCR & Trio Diagnostics Limited, ... organization. The transaction closed on November 17, 2014. ...
(Date:11/21/2014)... 2014 Clementia Pharmaceuticals, ... dass die Europäische Arzneimittel-Agentur (European Medicines ... Orphan-Medizinprodukt an Palovarotene vergeben hat, den ... von Fibrodysplasia ossificans progressiva (FOP). FOP ... Krankheit, die von schmerzhaften, wiederkehrenden Episoden ...
Breaking Medicine Technology:New CBD Oil From Industrial Hemp is Comparable to Charlotte's Web, Legal In All 50 States 2New CBD Oil From Industrial Hemp is Comparable to Charlotte's Web, Legal In All 50 States 3Abaxis Acquires UK-based Distribution Organization 2Abaxis Acquires UK-based Distribution Organization 3Abaxis Acquires UK-based Distribution Organization 4Clementia Pharmaceuticals erhält EMA-Kennzeichnung als Orphan-Medizin für Palovarotene zur Behandlung von Fibrodysplasia ossificans progressiva 2Clementia Pharmaceuticals erhält EMA-Kennzeichnung als Orphan-Medizin für Palovarotene zur Behandlung von Fibrodysplasia ossificans progressiva 3
... , , LINCOLNSHIRE, Ill. ... leading specialty distributor of health care products in the emergency ... has acquired CVC, Inc.  Headquartered in Arlington, Texas , ... respiratory and emergency medical services markets.   , The privately ...
... , Jan. 12 Stereotaxis (Nasdaq: ... has been approved by the U.S. Food and Drug ... the treatment of Type 1 atrial flutter.  The product ... on-going co-development agreement between Stereotaxis and Biosense Webster to ...
Cached Medicine Technology:Sarnova Announces Acquisition of CVC, Inc. to Expand Portfolio of Specialty Medical Products 2Sarnova Announces Acquisition of CVC, Inc. to Expand Portfolio of Specialty Medical Products 3Stereotaxis is Notified of the FDA Approval of an Additional Magnetic Irrigated Catheter 2Stereotaxis is Notified of the FDA Approval of an Additional Magnetic Irrigated Catheter 3
... PDCs computer-generated Thermal Printing Wristbands and ... direct thermal and thermal transfer printers. ... activate a heat-sensitive thermal coating under ... printers use heat to transfer highly ...
... Wristbands and Tags print in mere ... transfer printers. Direct thermal printers use ... coating under the bands protective surface. ... transfer highly durable ink from a ...
... coded patient identification bracelets (wristbands) and/or ... at patient care areas throughout the ... identification and in creating a positive ... back to the patient through the ...
... secure band is desired for adults and where an ... appropriate. The design allows for two bands to be ... on the wrist and the second to be held ... This is particularly useful in a hospital situation wherea ...
Medicine Products: