Navigation Links
Two Pivotal Vectibix® Phase 3 Studies in First and Second-Line Treatment of Metastatic Colorectal Cancer Published in the Journal of Clinical Oncology
Date:10/4/2010

pe) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Vectibix has been launched in more than 20 European Union countries, Russia, Israel, Switzerland, Australia, Canada and Japan. Applications in the rest of the world are pending.

Important U.S. Product Safety InformationWARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONSDermatologic 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 1 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 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.

Other common adverse events of special importance associated with Vectibix and/or EGFR monoclonal antibody therapies include dermatologic-related reactions, pulmonary complications, electrolyte disturbances and infusion-related re
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11

Related biology technology :

1. NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
2. Positive SPA Reply From the FDA for TopoTargets Pivotal Trial With Belinostat in PTCL
3. Fifth DuraHeart(TM) U.S. Implant Marks Important Milestone in U.S. Pivotal Trial
4. Oncolytics Biotech Inc. Announces Decision to Pursue Phase II/III Pivotal Clinical Trial
5. Genmab A/S: Ofatumumab Pivotal CLL Data to be Presented at ASH
6. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point
7. BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009
8. BioSyntech Achieves Enrolment Goal for Pivotal Trial of BST-CarGel(R), its Cartilage Repair Device
9. ExonHit Therapeutics Invested Strongly in 2008 for Pivotal 2009 Results
10. PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
11. BioMS Medicals pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/21/2015)... LA JOLLA, Calif. , April 21, 2015 ... (JCVI), a not-for-profit genomic research organization, published a ... manipulate a type of microalgae called diatoms. The ... , Ph.D. and senior author Philip Weyman ... methods will enable better understanding of diatom genetics ...
(Date:4/21/2015)... , April 21, 2015 Merrimack Pharmaceuticals, Inc. (Nasdaq: ... a multi-arm Phase 1 study of MM-141, a bispecific ... in an oral session by Dr. Mansoor Saleh ... Research Annual Meeting in Philadelphia, PA. ... MM-141 as a monotherapy and in combination with everolimus ...
(Date:4/21/2015)... ENGLEWOOD, Colo. , April 21, 2015 ... details for a scheduled investor call on Thursday, April ... in using the instructions as follows: ... toll-free number: (844) 789-4877 International toll number: (925) ... emailed in advance to Tina Amirkiai , ...
(Date:4/21/2015)... FOREST, Calif. , April 21, 2015 ... leading provider of advanced cryogenic logistics solutions ... including immunotherapies, stem cells, cell lines, clinical ... today announced that Dr. Mark W. ... at the 3rd Annual BioLogistics Summit in ...
Breaking Biology Technology:Scientists at the J. Craig Venter Institute Publish Paper Outlining Efficient Synthetic Biology Methods to Genetically Engineer Microalgae 2Scientists at the J. Craig Venter Institute Publish Paper Outlining Efficient Synthetic Biology Methods to Genetically Engineer Microalgae 3First-in-Human Phase 1 Trial of MM-141 Demonstrates Activity in Biomarker Positive Patients 2First-in-Human Phase 1 Trial of MM-141 Demonstrates Activity in Biomarker Positive Patients 3First-in-Human Phase 1 Trial of MM-141 Demonstrates Activity in Biomarker Positive Patients 4First-in-Human Phase 1 Trial of MM-141 Demonstrates Activity in Biomarker Positive Patients 5Ampio Announces Investor Call on Thursday, April 23, 4:30 p.m. ET 2Cryoport to Present at the 3rd Annual BioLogistics Summit in San Francisco, CA 2Cryoport to Present at the 3rd Annual BioLogistics Summit in San Francisco, CA 3
... Inc. (Amex: IMA ), a leading manufacturer ... and professional markets, announced,today that it will attend ... Conference being held May 28, 2008 at the ... Management, and Jon Russell, Vice,President, Finance, will attend. ...
... , - Production Increase Brings Large Disease ... AMT), a leader in the field,of human gene ... and Development Agreement from the National Heart, Lung, ... Health (NIH), Bethesda,Maryland, that promises to substantially enhance ...
... Screening and Treatment, and an Apparent Higher Prevalence ... Than in North America and Australia, BARCELONA, Spain, May ... women surveyed from Europe, North America, and,Australia reported having one ... women considered to be at high risk for a fracture, ...
Cached Biology Technology:Inverness Medical Innovations to Present at FBR Capital Markets 12th Annual Spring Investor Conference on May 28, 2008 2AMT's Cooperative Research and Development Agreement With NIH to Boost Production Capacity 2AMT's Cooperative Research and Development Agreement With NIH to Boost Production Capacity 3Global Study Reveals Differences in Standard of Care for Osteoporosis Across the World 2Global Study Reveals Differences in Standard of Care for Osteoporosis Across the World 3Global Study Reveals Differences in Standard of Care for Osteoporosis Across the World 4
(Date:3/23/2015)... SoundView Technology Group issues a new research update following the ... wallet. SoundView was one of the selected user groups to provide ... in multiple scenarios and outlets. Soundview shares ... both debit and credit card payments.  Soundview ... meets their plans in 2015, it would push our IV ...
(Date:3/20/2015)... DUBLIN , Mar. 20, 2015 Research ... announced the addition of the "India Sensors ... their offering. The sensor market is ... through 2020 Consumer electronics, automotive, industrial ... for sensors in the country. In addition, adoption ...
(Date:3/19/2015)... , March 19, 2015  NXT-ID, Inc. (NASDAQ: ... company focused on the growing mobile commerce market, announces its ... a news clip that aired this week on ... . In a segment "The Next Great Thing", ... ,a new way to pay, and ,a really big breakthrough ...
Breaking Biology News(10 mins):Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 3Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 4India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 2India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 3NXT-ID's Wocket Smart Wallet Featured on Fox News Segment, "The Next Great Thing" 2NXT-ID's Wocket Smart Wallet Featured on Fox News Segment, "The Next Great Thing" 3
... threatened? Hungry? Looking for a mate? Move! Tracking and remote ... find out what they are up to. However, general theories ... Ecology in the journal Proceedings of the National Academy ... organisms as diverse as gut bacteria, tree seeds, ants, marine ...
... in French . Plant researchers ... have announced a major breakthrough in a developmental process ... the reversal of what is called epigenetic silencing in ... a better understanding of gene regulation in the continuing ...
... sedentary lifestyles and filter-feeding habits, clams have been silent ... their waters. These clams are silent no more, ... Sea Lab and her colleagues have reported in their ... . Using stable isotope techniques, Carmichael demonstrated it ...
Cached Biology News:New movement models tested at the Smithsonian in Panama 2Plants display 'molecular amnesia' 2Plants display 'molecular amnesia' 3
... Immunogen KLH-conjugated, synthetic ... 54-75 (RRGPHRNPG-PGDDDGQRSRSSS) of mouse p19ARF. ... to amino acids 62-75. Clone ... Routinely evaluated by immunoblot. ...
EDG-1 Western blot control Source: Cell Lysate Application: Western Blotting Control...
Complete cell culture media with cytokines...
...
Biology Products: