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:10/25/2014)... SANTA MONICA, Calif. , Oct. 24, 2014 ... medtech leaders over friendly robotic competition at the  ... Conference on October 29-30 th at ... The event will highlight local student built robots ... and Technology" (FIRST) competition.  FIRST students and mentors ...
(Date:10/25/2014)... Oct. 24, 2014   Metanome, Inc. , a ... services and data analysis, was the genomic sequencing provider ... Phase I/II clinical trial of SER 109, an Ecobiotic® ... Clostridium difficile infections (CDI). Metanome has ... R&D and clinical programs. Such genomic characterization has enabled ...
(Date:10/25/2014)... HILL, N.C. , Oct. 24, 2014 /PRNewswire/ ... teams can provide a company access to diverse ... emerging markets, and round-the clock business hours for ... overcoming difficult hurdles. According to ... team disappointments, such as seeing a project not ...
Breaking Medicine Technology:Local robotics teams compete - a "FIRST" at next week's MD&M Minneapolis- October 29-30th at the Minneapolis Convention Center 2Local robotics teams compete - a "FIRST" at next week's MD&M Minneapolis- October 29-30th at the Minneapolis Convention Center 3Metanome Selected as Metagenomics Provider for Seres Health Clinical Trial 2Work Around the Clock: Successfully Building & Managing Global Virtual Teams 2
... Amicus Therapeutics (Nasdaq: FOLD ) today announced ... No. 7,501,439, titled "Tartrate Salt of Isofagomine and Methods of ... isofagomine, the active ingredient in the Company,s investigational drug Plicera(TM) ... disease. The patent will expire in 2027. John ...
... CONFIRM SAFETY AND EFFICACY FOR ROOM TEMPERATURE STORAGENANTONG ... Bulletin Board: SNBP) is pleased to announce that ... skeletal muscle relaxant marketed as Kutai in China, ... multi-center Phase IV Clinical Study investigated the safety ...
Cached Medicine Technology:Amicus Therapeutics Announces Issuance of New Plicera(TM) Composition of Matter Patent 2Amicus Therapeutics Announces Issuance of New Plicera(TM) Composition of Matter Patent 3Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing 2Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing 3
(Date:10/25/2014)... CA (PRWEB) October 25, 2014 More ... annual President’s Circle Reception on Monday at the home ... accomplishments and hear from guest speaker Dr. Winifred Lender ... worlds. , Dr. Lender, a Santa Barbara psychologist, author ... challenges and benefits of living in the digital age. ...
(Date:10/25/2014)... QueenBeeTickets.com has a variety of tickets for online ... Bob Seger & The Silver Bullet Band tickets for ... going on sale October 25 and are expected to ... the selection of tickets for Bob Seger & The ... is touring North America beginning next month, and he ...
(Date:10/25/2014)... Oct. 24, 2014 (HealthDay News) -- Interrupting blood supply to ... reduce the risks associated with the surgery, according to a ... stop the blood supply to the heart to be able ... the heart will reduce its ability to produce energy because ... flow to another large muscle, such as an arm or ...
(Date:10/25/2014)... Current osteoporosis screening guidelines and tools fail to ... osteoporosis-related fractures, a new study says. "If ... that help us accurately predict who will suffer ... these at-risk people for preventive measures," study author ... division of general internal medicine and health services ...
(Date:10/22/2014)... October 22, 2014 On October 22, ... featuring skin diseases both fictional and real. The ... a nonprofit organization committed to advocacy and philanthropy in ... will take the opportunity to impart truth and clarity ... , There are many misconceptions about Morgellons Disease ...
Breaking Medicine News(10 mins):Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 2Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 3Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 4Health News:QueenBeeTickets.com Features Bob Seger & The Silver Bullet Band Tickets for Charleston Civic Center, Huntington Center, and Nationwide Arena at Reduced Prices 2Health News:Brief Interruption of Blood Supply to Limb Might Aid Heart Surgery: Study 2Health News:Osteoporosis Screening Guidelines May Miss Younger Women at Risk 2Health News:CBS’ Criminal Minds takes aim at skin disease with Morgellons in the Mix 2Health News:CBS’ Criminal Minds takes aim at skin disease with Morgellons in the Mix 3
... clinical trials on a new investigational drug being developed ... been successfully completed. Completion of the initial phase ... prepared by researchers at Cardiff University,s Welsh School of ... an approved medicine have significantly improved. Approximately ...
... N.C. Millions of patients with advanced disease in palliative ... easily. But a new study from Duke University Medical ... intervention, and among those who do benefit, it doesn,t make ... just plain old room air both offer equal benefit. ...
... Reporter , THURSDAY, Sept. 2 (HealthDay News) -- An ... two hours, making only one doctor visit necessary before ... advance against a disease that kills nearly 2 million ... "This is a very important discovery," said infectious disease ...
... and a little serendipity led a Northwestern University research team ... used for gas storage and food and medical technologies. And ... first known all-natural metal-organic frameworks (MOFs) that are simple to ... the Northwestern MOFs you can pop into your mouth and ...
... Stem cells might be thought of as trunks in the ... can turn into a dazzling variety other cellskidney, brain, heart ... the capacity to turn into virtually any cell type in ... of cell therapies, the conquering of age-old diseases or even ...
... September, 2010 - Elsevier announced today the publication of ... Andropause Society (EMAS) in the journal Maturitas ... post-reproductive health of women. The statements cover the ... epilepsy, endometriosis and premature ovarian failure. Each statement ...
Cached Medicine News:Health News:First clinical trials successfully completed on potent new hepatitis C drug 2Health News:Study challenges value of oxygen therapy in end-of-life care 2Health News:Study challenges value of oxygen therapy in end-of-life care 3Health News:Experimental TB Test Called Fast and Accurate 2Health News:Experimental TB Test Called Fast and Accurate 3Health News:Edible nanostructures 2Health News:Edible nanostructures 3Health News:Study finds that cancer-causing gene crucial in stem cell development 2Health News:Study finds that cancer-causing gene crucial in stem cell development 3Health News:EMAS publishes position statements about the post-reproductive health of women 2
1.0% Tryptone, 0.5% Yeast Extract, 1.0% Sodium Chloride, 7.5% Glycerol....
Luria bertani broth: 1.0% Tryptone, 0.5% Yeast Extract, 1.0% Sodium Chloride....
Inoculum Broth with Calcium Chloride and Phytone....
12% Tryptone, 24% Yeast Extract, 4.0% Glycerol. Supplied with 1 liter of 10x phosphate buffer (0190-1L)....
Medicine Products: