Navigation Links
Amgen Statement on CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer
Date:3/18/2011

the U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was 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 progression-free survival. 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 colorectal cancer with these mutations.(x)

In December 2007, the European Medicine Agency (EMA) 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.(xi) Vectibix has been launched in more than 30 European Union countries, Russia, Israel, Switzerland, Australia, Canada and Japan. Applications in the rest of the world are pending.

Important European Product Safety InformationFor full prescribing information please see the Summary of Product Characteristics.

Vectibix is indicated as monotherapy for the treatment of patients with EGFR-expressing, metastatic colorectal carcinoma (mCRC) with nonmutated (wild-type) KRAS 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 interstitial pneumonitis or pulmonary fibrosis.

Othe
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related biology technology :

1. Amgen to Present at the Cowen and Company 31st Annual Healthcare Conference
2. Amgen Announces Webcast of 2010 Fourth Quarter and Full Year Financial Results
3. Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass
4. Amgen and Xencor Enter Option Deal to Co-Develop Xencors Novel Antibody for Autoimmune Diseases
5. Call for Applications: The Amgen Award for Science Teaching Excellence
6. Amgen Foundation Recognizes Outstanding Staff Volunteers and Contributes $55,000 to Their Favorite Local Nonprofits
7. Amgen to Provide Testimony at FDA Hearing on Biosimilars
8. Amgen Highlights Data to Be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
9. Amgens Roger M. Perlmutter, M.D., Ph.D., Named 2009 AAAS Fellow, Recognized for Discovery, Development of Novel Medicines
10. Array BioPharma and Amgen Partner in Type 2 Diabetes
11. Amgen to Present at Lazard Capital Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... Baylor Research Institute (BRI) at Dallas ... in Phoenix, AZ , today announce ... treatments for patients with a broad range of cancers. Aligning ... clinical trials and access to technology to drive the development ... bedside across Baylor Scott & White Health,s 49 ...
(Date:5/21/2015)... YORK , May 21, 2015  Susan ... Research (FPWR), a nonprofit organization dedicated to supporting ... Prader-Willi syndrome (PWS), announced today that FPWR has ... and Irina Shaulov contributed $1 million ... clinical initiatives.  ...
(Date:5/21/2015)... May 21, 2015 Imagine being ... - and those of others. Being able to read ... and read people to anticipate their thoughts and actions ... emotions and feelings to create unique abstract paintings and ... games. Get inside a first-person-shooter as it creates action, ...
(Date:5/21/2015)... (PRWEB) May 21, 2015 As part ... Medical Center (BDWMC), Sun Health Foundation funded a $3.25 ... new inpatient pharmacy with the most up-to-date features and ... June 2. The pharmacy's 45 staff members will begin ... 4,895-square-foot space in the coming days. , The ...
Breaking Biology Technology:Precision Medicine Collaboration to Increase Options for Cancer Patients 2Precision Medicine Collaboration to Increase Options for Cancer Patients 3Precision Medicine Collaboration to Increase Options for Cancer Patients 4The Foundation for Prader-Willi Research Receives $1M Contribution in Support of Clinical Initiatives 25 Days to Meet ARGUS - The World's First Contactless Emotions Scanner 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 3
... , ALISO VIEJO, Calif., Sept. 1 ... become an Agilent Certified Service Provider on the Agilent microarray ... (aCGH) which is an application used by researchers to discover ... , (Logo: http://www.newscom.com/cgi-bin/prnh/20090428/LA06744LOGO ) , ...
... , FRAMINGHAM, Mass. and SYDNEY, ... ) (ASX: HIN) today confirmed that trading of its CHESS ... temporarily suspended for the reasons stated below. In consequence, ... temporarily suspended. Based on discussions with representatives of NASDAQ ...
... AMSTERDAM, September 1 SynCo Bio Partners ... biopharmaceuticals,announced today that it has expanded its business into ... to manufacture a live biotherapeutic,for an emerging Japanese pharmaceutical ... product is an innovative live biotherapeutic,based anticancer drug. The ...
Cached Biology Technology:Ambry Genetics Announces Certified Service Provider Status for Agilent Microarrays 2HeartWare International, Inc. Temporary Suspension of Trading 2HeartWare International, Inc. Temporary Suspension of Trading 3SynCo Bio Partners Enters the Japanese Market as it Signs its First Agreement With a Japanese Pharmaceutical Company 2
(Date:5/20/2015)... May 20, 2015 NXT-ID, Inc. (NASDAQ: ... wholly owned subsidiary, 3D-ID LLC, a company engaged in ... for the biometrics technology portion of the recently awarded ... the Department of the Army. 3D-ID LLC ... for government, law enforcement and security agencies. ...
(Date:5/14/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/5whpxg/fingerprint ... Sensors Market in Smart Mobile Devices " report ... 2014 was a watershed year for fingerprint sensors in ... Pay,. Apple gave fingerprint sensors a raison d,etre in ... sensors are a must-have feature in flagship smartphones. ...
(Date:5/10/2015)... , May 11, 2015 Fingerprint Cards ... FPC1025 and FPC1155 from the distributor World Peace Industrial Group ... distributors in Asia . Deliveries are planned ... be used by smartphone manufacturers in China ... the communicated revenue guidance of + 1 000 MSEK for 2015. ...
Breaking Biology News(10 mins):NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 2NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 3Global Smart Mobile Devices Fingerprint Sensors Market 2015-2019: Key Vendors are Authentec, Validity Sensors, Fingerprint Cards, Next Biometrics Group. IDEX, and Qualcomm 2Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 235 Million 2
... eat affect the intensity of its taste? It depends on ... Pickering and colleagues from Brock University in Canada. Their work ... have an effect on the intensity of sour, bitter and ... is published online in Springer,s Chemosensory Perception journal. ...
... Journalists may now apply for press accreditation ... (ACS) 244 th National Meeting & Exposition, Aug. ... described national meetings of ACS ― the world,s largest ... because of the scope and importance of the scientific ...
... Julian Hiscox and Dr John Barr of the University,s Faculty ... Porton (HPA) to build a bank of molecular signatures that ... changes seen in cells. Currently the team is barcoding different ... - a virus associated with the onset of asthma in ...
Cached Biology News:To get the full flavor, you need the right temperature 2Virus 'barcodes' offer rapid detection of mutated strains 2
The PxE Thermal Cycler (PxE) is a licensed 96 well PCR machine, developed to provide all fundamental features for value for money thermal cycling....
... The Px2 Thermal Cycler is Thermo Electron's ... to date with easy to use sophisticated ... for easy programming. Designed to offer performance, ... Px2 incorporates a number of customer driven ...
For testing the AQUA technique on your MS instruments....
The Lambda Control Kit contains lambda DNA and two 25mer primers, which can be used to amplify a 500bp fragment. The lambda DNA is purified by CsCl gradient centrifugation and organic extraction foll...
Biology Products: