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:12/19/2014)... 18, 2014 Radiology information ... is used to store, manipulate, and distribute patient ... patient tracking and scheduling system, result reporting, and ... with HIS and other databases improves the hospital ... patient scheduling, patient list management, radiology department workflow ...
(Date:12/19/2014)... REDWOOD CITY, Calif., Dec. 18, 2014 ... on the development of medical diagnostics based on ... of gas flow, today announced financial results for ... 30, 2014. "Following the completion of ... well positioned to maximize the recently initiated CoSense® ...
(Date:12/19/2014)... and LYON, France , Dec. 19, ... LLY ) and Adocia (Euronext Paris: FR0011184241 – ADOC) ... an ultra-rapid insulin, known as BioChaperone Lispro, for treatment ... BioChaperone Lispro relies on Adocia,s proprietary BioChaperone® technology and ... and Adocia will develop BioChaperone Lispro with the goal ...
Breaking Medicine Technology:The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 2The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 3Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3
... , NEW YORK, ... research report is available in its catalogue: , ... , http://www.reportlinker.com/p0164335/Cardiac-Pacemakers---A-World-Market-Analysis.html , Pacemaker devices constitute ... market. The worldwide cardiac pacemakers market is characterized by ...
... ... a new market research report is available in its ... Global Market Perspective , http://www.reportlinker.com/p0164320/Electrodes-for-Medical-Devices---A-Global-Market-Perspective.html , ... muscle and nerve cells that are created by chemical ...
Cached Medicine Technology:Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 2Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 3Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 4Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 5Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 6Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 7Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 8Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 9Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 10Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 2Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 3Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 4Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 5Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 6Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 7
(Date:12/19/2014)... December 20, 2014 Today, Balfleet.com ... special-occasion outfits, announces its formal dress promotion. All the ... up to 60% off. , Balfleet.com is well-known for ... bridesmaid dresses, prom dresses, cocktail dresses and more. Its ... 30-day money-back guarantee, and they can create an elegant ...
(Date:12/19/2014)... 19, 2014 Energy Textiles is ... now available. Celliant, the world’s leading responsive textile, ... pillowcases. , There are a number of benefits ... increased oxygenation and balanced body temperature; which can ... pain relief; enhanced athletic performance; and overall wellness. ...
(Date:12/19/2014)... OK (PRWEB) December 19, 2014 Eufaula, ... home to Lake Eufaula, the state’s largest lake with ... lakeside town is home to a little more than ... 1:00 P.M. on Saturday, the 6th of December. , ... its way through downtown Eufaula on Main Street. ...
(Date:12/19/2014)... print component of Vision and Hearing is distributed within ... with a circulation of approximately 230,433 copies and an ... nationally through a vast social media strategy and across ... To explore the digital version of the campaign, ... exclusive interview with Mark DeMontis , sharing his experience ...
(Date:12/19/2014)... News) -- Potentially illness-causing E. coli bacteria were found ... according to a new study. Researchers checked cilantro, ... farmers markets in Los Angeles and Orange counties in ... 150 samples tested, 24 percent were positive for E. ... the researchers. Both types of bacteria can cause ...
Breaking Medicine News(10 mins):Health News:Balfleet.com Announces Its Formal Dress Promotion For 2015 2Health News:Energy Textiles Launches Celliant Revitalizing Bedsheets 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Mark DeMontis, Founder of Courage Canada, shares his passion for bringing hockey to those affected by blindness in Mediaplanet’s “Vision and Hearing” campaign 2Health News:E. Coli Germs Found on Farmers Market Herbs 2
... to varying degrees, that cigarette smoking causes cancer, the ... have// sued them, reveals an analysis of recent lawsuits, ... ,The authors looked at the opening and closing statements ... personal injury claims brought against major tobacco manufacturers between ...
... a major out break of hepatitis A, a viral infection, ... cases have been// identified for treatment, so far. Most of ... happen to be students from the Elmbank Middle school. ... from the West end of Toronto have been given vaccinations ...
... stem cells are primarily responsible for the relapse of colon ... grow into any tissue. ,Earlier researches have shown ... always return . These include breast cancer, blood cancer and ... of Toronto told reporters that researchers were aware that stem ...
... the scheme proposed to evaluate overseas trained doctors, has not ... public by the Council of Australian Governments (COAG) and was ... be need of the hour especially after a furore at ... 17 patients., ,AMA president Dr Mukesh Haikerwal said, ...
... gave the ‘go-ahead’ to market a genetically-engineered (GE) rice ... a// mess just 3 months ago regarding its alleged ... to market this crop came as a shock, especially ... plans of commercialization of the crop. ,Joseph ...
... cats and dogs over fears of the spread of bird ... cats so as to prevent further spreading// of the H5N1 ... a chicken farm last week. Animal health experts suggested that ... was no scientific evidence that cats or dogs could pass ...
Cached Medicine News:Health News:Fear Factor in Toronto: health officials fight Hepatitis A outbreak 2
... The PowerPac HV high-voltage power supply, with temperature ... output of 5,000 V, 500 mA, and 400 ... gel temperature between 0 and 90 degrees C ... data transfer. Power cord and instructions are provided. ...
... power supply, 100-120 and 220-240 ... V, 4-400 mA, and 75 ... built-in switch when using either ... power cord. Power cord and ...
... Ultrapure MB Grade PRODUCT SPECIFICATIONS Form: Granular, free-flowing ... to 0.05 Gel Point (3%): less than or equal ... to 75C Gel Strength (3%): greater than or equal ... equal to 10% Sulfate: less than or equal to ...
Agarose L03 is recommended for separations of DNA fragments = 1,000 bp....
Medicine Products: