Navigation Links
Vectibix® (Panitumumab) Granted Approval for Expanded Indications in the European Union
Date:11/15/2011

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.(7)

Important U.S. Product Safety Information (Monotherapy)

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 Precautions (5.2), and Adverse Reactions (6.1, 6.3)].

The most common adverse events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.

Important European Product Safety Information

  • Vectibix has been approved in the European Union for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC):
    • in first-line in combination with FOLFOX
    • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
    • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
  • Vectibix is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to the product and in patients with in
    '/>"/>

SOURCE Amgen Europe GmbH
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Amgen to Appeal CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer in Europe
2. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
3. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
4. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
5. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
6. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
7. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
8. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
9. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
10. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
11. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ... Consumables Market - Global Industry Analysis, Size, Share, Growth, ... their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ... are used on patients in order to treat dental ...
(Date:1/15/2014)... THOUSAND OAKS, Calif. , Jan. 15, 2014 ... and Amgen (NASDAQ: AMGN ) announced ... to jointly discover and validate new therapeutic targets ... (IBD), a chronic disorder that affects millions worldwide. ...
(Date:1/15/2014)... , Jan. 15, 2014  In an unprecedented effort to curb ... in ambulances and other transport vehicles, an advanced and portable UV ... personnel for the first time. In order to ... these deadly pathogens, West Palm Beach Fire ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Superbugs No Longer Ride In Rescue Vehicles 2
... and GAITHERSBURG, Md., May 30, 2012   Life Technologies ... OpGen, Inc ., a commercial stage whole genome analysis ... agreement to develop systems, technologies and applications intended to ... the public health and infectious disease markets. ...
... of Opioid Management is presenting the ... the Joseph B. Martin Conference Center at Harvard Medical School. ... clinical application, and compliance, will address the proper use, and ... According to a recent National Survey on Drug Use and ...
Cached Medicine Technology:Life Technologies and OpGen Sign Collaborative Agreement to Leverage Ion Torrent and Whole Genome Mapping Technologies 2Life Technologies and OpGen Sign Collaborative Agreement to Leverage Ion Torrent and Whole Genome Mapping Technologies 3Life Technologies and OpGen Sign Collaborative Agreement to Leverage Ion Torrent and Whole Genome Mapping Technologies 4Unique Conference Tackles Opioid Abuse Epidemic 2
(Date:4/24/2014)... NH, 4/24/14) Dartmouth has been awarded one of ... serve as a Lead Academic Participating Site in its ... Award recipients are a select groups of investigators charged ... fewer cooperative groups., The NCTN grant system reflects recommendations ... It streamlines operations to achieve four goals:, ...
(Date:4/24/2014)... Orleans, LA The National Science Foundation has ... Research Experiences for Undergraduates (REU) Site grant in ... the training of undergraduates from diverse social and ... the New Orleans area. The project will ... the summers of 2014-16. It will be ...
(Date:4/24/2014)... research led by a scientist at the University of ... element in the development of the nervous system may ... breast cancer., A research team, led by Dr ... Department of Biology at York, has studied how voltage-gated ... These channels are found in the membranes of excitable ...
(Date:4/23/2014)... was safe and effective in treating patients with ... , according to a new pilot study published ... online. Known as fecal microbiota transplantation, the treatment ... or a nasogastric tube. The findings suggest approaches ... available to patients. , A growing concern, ...
(Date:4/23/2014)... Moffitt Cancer Center researchers say clinical trials for ... leukemia (AML) are very promising. Patients treated with ... and daunorubicin, are showing better responses than patients ... , "Acute myeloid leukemia is an aggressive ... success, especially in older patients," explained Jeffrey Lancet, ...
Breaking Medicine News(10 mins):Health News:Dartmouth awarded lead role in NCI clinical trials network 2Health News:Dartmouth awarded lead role in NCI clinical trials network 3Health News:Breast cancer replicates brain development process 2Health News:Pilot study suggests ways to widen access to fecal transplants for C. diff infections 2Health News:Moffitt Cancer Center's phase 3 study may be game-changer for acute myeloid leukemia 2
... Elsevier announced today that major global ... Germany, has signed an agreement to purchase EMBASE ... first time, EMBASE Classic is a fully digitized ... Journals published between 1947 and 1973. Covering ...
... randomized, controlled, multi-center trial has found that cardiac ... uptake during exercise testing, the trial,s primary endpoint, ... mechanical problems that disrupt the heart,s normal rhythm ... on EKG. , The Resynchronization Therapy in Narrow ...
... OSTE ) announced today that third quarter 2007 revenue ... revenue of $23.4,million. Revenue from Osteotech,s "core" DBM and ... months ended September 30,2007 as compared to revenue of ... of 2006. Gross margin improved to 55% in the ...
... Nov. 6 EntreMed, Inc.,(Nasdaq: ENMD ), ... of cancer and inflammatory diseases, today,reported results for ... (Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO ) Revenues ... $3,023,000 for the comparable period a year ago. ...
... (Pink Sheets: BIEL), announced today that Michael Seidenman,R. ... President of Sales. Mr. Seidenman is a ... versed in electro medicine devices. He brings to,the ... sales,management. Mr. Seidenman has launched many new products, ...
... Nov. 6 /PRNewswire-FirstCall/ - Response Biomedical,Corporation (TSX-V: RBM, ... Stock Exchange (TSX) has conditionally approved the Company,s,application ... Listing on the TSX,will be subject to the ... Company will issue a news release when final ...
Cached Medicine News:Health News:EMBASE Classic makes inroads into pharmaceutical industry 2Health News:Study puts brakes on extending indications for cardiac resynchronization therapy 2Health News:Osteotech Reports 2007 Third Quarter Financial Results; Core Segment Revenue Increased 28%; Gross Margin Improved to 55%; Diluted Earnings Per Share of $.09 2Health News:Osteotech Reports 2007 Third Quarter Financial Results; Core Segment Revenue Increased 28%; Gross Margin Improved to 55%; Diluted Earnings Per Share of $.09 3Health News:Osteotech Reports 2007 Third Quarter Financial Results; Core Segment Revenue Increased 28%; Gross Margin Improved to 55%; Diluted Earnings Per Share of $.09 4Health News:Osteotech Reports 2007 Third Quarter Financial Results; Core Segment Revenue Increased 28%; Gross Margin Improved to 55%; Diluted Earnings Per Share of $.09 5Health News:EntreMed Reports Third Quarter 2007 Financial Results 2Health News:EntreMed Reports Third Quarter 2007 Financial Results 3Health News:EntreMed Reports Third Quarter 2007 Financial Results 4Health News:EntreMed Reports Third Quarter 2007 Financial Results 5Health News:BioElectronics Corporation Announces Addition of Michael Seidenman, R.Ph. as Vice President of Sales 2Health News:Response Biomedical Corporation Receives Conditional Listing Approval from the Toronto Stock Exchange 2Health News:Response Biomedical Corporation Receives Conditional Listing Approval from the Toronto Stock Exchange 3
... offers state-of-the-art quality in an instrument of ... durability. Low profile cutting tips allow access ... I instruments are available in just about ... required for large and small joint arthroscopic ...
... Instrument program offers state-of-the-art quality in an ... strength and durability. Low profile cutting tips ... spaces. Series I instruments are available in ... and angle required for large and small ...
... Series I Instrument program offers state-of-the-art quality ... while maintaining strength and durability. Low profile ... tight joint spaces. Series I instruments are ... style, size and angle required for large ...
... program offers state-of-the-art quality in an instrument ... and durability. Low profile cutting tips allow ... Series I instruments are available in just ... angle required for large and small joint ...
Medicine Products: