Navigation Links
Novartis Drug Afinitor® Recommended by FDA Oncology Advisory Committee for Approval to Treat Advanced NET of Pancreatic Origin
Date:4/12/2011

t of RADIANT-3 is progression-free survival (PFS). Secondary endpoints include safety, objective response rate (confirmed according to RECIST), duration of response and overall survival(1).

Results from the trial showed that everolimus more than doubled median PFS from 4.6 to 11.0 months when compared with placebo and reduced the risk of cancer progression by 65% (hazard ratio=0.35 [95% CI, 0.27 to 0.45]; p<0.001) in patients with advanced pancreatic NET(1).

In the study, everolimus maintained a safety profile consistent with the prescribing information and previous studies of the drug. The most frequent all grade, drug-related adverse events (greater than or equal to 20%) were stomatitis/oral mucositis/ulcers (64% everolimus vs. 17% placebo; includes stomatitis, aphthous stomatitis, mouth ulceration and tongue ulceration), rash (49% vs. 10%), diarrhea (34% vs. 10%), fatigue (31% vs. 14%), infections (23% vs. 6%), nausea (20% vs. 18%), peripheral edema (20% vs. 3%) and decreased appetite (20% vs. 7%); most were grade one or two. Grade three and four adverse events (greater than or equal to 5%) include stomatitis/oral mucositis/ulcers (7% vs. 0%; includes stomatitis, aphthous stomatitis, mouth ulceration and tongue ulceration), anemia (6% vs. 0%) and hyperglycemia (5% vs. 2%). Median exposure to everolimus was 2.3-fold longer than exposure to placebo (38 vs. 16 weeks)(1).

About Afinitor (everolimus)Afinitor® (everolimus) tablets is approved in the US for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and in the European Union (EU) for the treatment of patients with advanced RCC whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

Afinitor is also approved in the US to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeut
'/>"/>

SOURCE Novartis Pharmaceuticals Corporation
Copyright©2010 PR Newswire.
All rights reserved

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

Related medicine technology :

1. US Supreme Court Denies Certiorari and Thereby Leaves in Place Second Circuit Ruling That Novartis Pharmaceuticals Corporation Must Pay its Sales Representatives Overtime Compensation
2. Novartis Gains FDA Approval for Amturnide™, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
3. Study Shows Novartis Drug Afinitor® Plus Hormonal Therapy Delays Disease Progression in Advanced Metastatic Breast Cancer Patients
4. Novartis Phase II LBH589 data show substantial disease control and tumor reduction in extensively pretreated Hodgkin lymphoma patients
5. Phase III Data Published in Lancet Show Novartis Drug Zometa® Improves Overall Survival in Newly Diagnosed Multiple Myeloma Patients
6. Final Approval of Novartis Gender Discrimination Settlement Slated for November 19
7. Study in NEJM Shows Novartis Drug Afinitor® Reduces Size of SEGAs, Benign Brain Tumors Associated with Tuberous Sclerosis
8. VIDEO from thenewsmarket.com and Novartis: Novartis drug Afinitor® Approved by FDA as First Medication for Children and Adults With a Benign Brain Tumor Associated With Tuberous Sclerosis
9. Novartis to Expand Global Research Headquarters in Cambridge, MA
10. VIDEO From thenewsmarket.com and Novartis: Phase III Data Show That Novartis Meningococcal Vaccine Menveo® Demonstrated Robust Immunogenicity in Infants
11. Analysis Shows Novartis Drug TOBI® Associated With Reduced Mortality in Cystic Fibrosis Patients With Common Lung Infection
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ... the "Dental Consumables Market - Global Industry ... - 2018" report to their offering. ... ) Dental consumables are products which are ... impairments, for tooth restoration and in treatment of ...
(Date:1/15/2014)... , Jan. 15, 2014  Novation, the leading ... company, awarded several new IT value-added reseller (VAR) ... hospital organizations with IT goods and services at ... agreements, as well as value-added services such as ... New Novation agreements were awarded to ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 ... that it has waived the Office of Fair Trading (OFT) ... the outstanding shares of ViroPharma Incorporated (NASDAQ: VPHM).   ... no longer conditional on OFT approval, and Shire expects to ... currently scheduled expiration time, subject to the satisfaction of all ...
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 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
... Products Company, Inc. has announced the addition of Florida ... Systems. Florida Metrology, based in Jupiter, ... Systems is a line of highly accurate portable metrology ... across the United States. Tim Row of Florida Metrology ...
... FOUNTAIN HILLS, Ariz., Dec. 8, 2010 Sunridge International ... that Ameco Medical is preparing to start the short ... Ameco Medical Equipment L.L.C., Sunridge,s exclusive distributor for ... Bores, Sunridge,s medical consultant, to attend the start of ...
Cached Medicine Technology:Florida Metrology To Distribute OASIS Inspection Systems 2
(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
... INDIANAPOLIS An orphan drug originally used for HIV treatment ... additional sensitivity and pain from opioid use. The study by ... in the March 25, 2011 issue of Brain, Behavior ... in animal models may ultimately make morphine a safer and ...
... , THURSDAY, March 24 (HealthDay News) -- Children ... control more quickly and accurately than those without the ... characterized by repeated involuntary sounds and physical movements called ... or -- in rare adult cases -- blurting out ...
... is available in French and Spanish . ... of Granada , belonging to the Laboratorio de Ciencias de la ... night vision, and the tool required to implement it, which has ... Software Halo v1.0, and a computer where the mouse is used ...
... Nick Harvey of the MRC Lifecourse Epidemiology Unit, Southampton, ... of Lige, Lige, Belgium were presented with the ESCEO ... at a ceremony held during the European Congress on ... Spain. The Awards, valued at 2,500, recognize young ...
... China, investigated eye movements in Chinese and British people to ... how they compare between different human populations. They found ... British people, is much more common in Chinese people, suggesting ... different populations. Tests of eye movements can ...
... Even mild stress can cause long-term disability that prevents people ... been known that mental disorders can be a cause of ... forms of stress should be taken more seriously, according to ... Kingdom, and colleagues. The study included over 17,000 employed ...
Cached Medicine News:Health News:A safer, more effective morphine may be possible with Indiana University discovery 2Health News:Children With Tourette Syndrome Have Better Motor Control, Study Finds 2Health News:Researchers develop a halometer that tests alterations in night vision 2Health News:Researchers develop a halometer that tests alterations in night vision 3Health News:Eye movement differs in British and Chinese populations 2Health News:Even Mild Stress Can Lead to Disability, Study Says 2
... offers accuracy, speed, ease of use, ... is an Auto Refractor/Keratometer with both ... elevation, automatic alignment, focusing, printing, high-speed ... other features that have made the ...
Neomycin and Polymyxin B Sulfates and Hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use....
Neomycin and Polymyxin B Sulfates and Hydrocortisone ophthalmic suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use....
Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical applications....
Medicine Products: