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

limited treatment options(1,2,3).

Earlier this year, the FDA granted everolimus priority review designation for the application and proposed indication for the treatment of advanced NET of gastrointestinal (GI), lung or pancreatic origin. Based on feedback from the FDA, Novartis amended the proposed indication to focus on patients with one specific type of NET, advanced NET of pancreatic origin.

Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months(8). There is the potential that the outcome of an ODAC meeting could result in the FDA extending the review period.

Worldwide regulatory filings for everolimus as a treatment for advanced NET of GI, lung or pancreatic origin are being reviewed by health authorities.

About pancreatic neuroendocrine tumors (NET)Neuroendocrine tumors arise from cells that can produce and secrete a variety of hormones that regulate bodily functions(9). These tumors can occur anywhere in the body; however, most are found in the pancreas, gastrointestinal tract or lungs(7,10). Pancreatic NET, also known as islet cell tumors, is a rare type of cancer that is different from pancreatic exocrine cancer, generally referred to as pancreatic cancer(6,11). There are currently limited treatment options for pancreatic NET patients(3).

About RADIANT-3RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care (BSC) versus placebo plus BSC in 410 patients with advanced, low- or intermediate-grade pancreatic NET. Patients who met the study entry criteria were randomized 1:1 to receive either everolimus 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in conjunction with BSC(1).

The primary endpoin
'/>"/>

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:5/28/2015)... 2015 This report analyzes the worldwide markets for ... following Segments: Standard Intraocular Lenses, and Premium Intraocular Lenses. The ... Canada , Japan , ... Latin America , and Rest of World. Annual estimates ... Also, a seven-year historic analysis is provided for these markets. ...
(Date:5/28/2015)... , May 28, 2015 ... has announced the addition of the  "North ... And Forecasts (2014 - 2019)"  report to ... Ultrasound is a type of ... look at body parts and structures inside ...
(Date:5/28/2015)... May 28, 2015 KaloBios Pharmaceuticals, Inc. (Nasdaq: ... Ronald A. Martell , to the position of Executive ... the KaloBios Board of Directors. In this new role, ... team to refine and execute on the strategic plan ... developing therapeutics for orphan oncology indications with high unmet ...
Breaking Medicine Technology:World Intraocular Lenses Industry 2World Intraocular Lenses Industry 3World Intraocular Lenses Industry 4World Intraocular Lenses Industry 5World Intraocular Lenses Industry 6World Intraocular Lenses Industry 7World Intraocular Lenses Industry 8World Intraocular Lenses Industry 9World Intraocular Lenses Industry 10World Intraocular Lenses Industry 11World Intraocular Lenses Industry 12World Intraocular Lenses Industry 13World Intraocular Lenses Industry 14World Intraocular Lenses Industry 15World Intraocular Lenses Industry 16World Intraocular Lenses Industry 17World Intraocular Lenses Industry 18World Intraocular Lenses Industry 19World Intraocular Lenses Industry 20World Intraocular Lenses Industry 21World Intraocular Lenses Industry 22World Intraocular Lenses Industry 23World Intraocular Lenses Industry 24World Intraocular Lenses Industry 25World Intraocular Lenses Industry 26North America Ultrasound Devices Market Report 2014-2019 - Technology and Applications 2KaloBios Appoints Ronald A. Martell Executive Chairman 2KaloBios Appoints Ronald A. Martell Executive Chairman 3KaloBios Appoints Ronald A. Martell Executive Chairman 4KaloBios Appoints Ronald A. Martell Executive Chairman 5
... Adeona Pharmaceuticals, Inc. (AMEX: AEN ), a ... diseases, announced today that it will hold a conference ... study evaluating reaZin for the dietary management ... April 15, 2011, at 8:00 a.m. (HAST)/2:00 p.m. (EDT). ...
... BATESVILLE, Ind., April 14, 2011 Hill-Rom (NYSE: ... on Tuesday, May 24, 2011 in New York City.  John ... executives will host investors and analysts to discuss the company,s ... webcast the entire conference beginning at 9 a.m. EDT on ...
Cached Medicine Technology:Adeona to Host Conference Call 2
(Date:5/29/2015)... Javlin continues to fulfill its worldwide ... a larger team, with the intention to better serve ... in the U.S. and Canada. , Javlin Inc., the ... growth in 2014 with its strongest earnings to date, ... platform, CloverETL. To accelerate further progress and ensure exceptional ...
(Date:5/29/2015)... (PRWEB) May 29, 2015 The annual aesthetic ... Surgery (ASAPS), was held in Montreal from May 14-19th. ... for aesthetic professionals from around the world; dedicating itself exclusively ... the many renowned plastic surgeons to attend this ... the six-day event, Dr. Vitenas was given the honor of ...
(Date:5/29/2015)... Healthpointe is excited to announce that they are now ... in Orange County. The Supartz Therapy is a cost-effective, ... for patients with osteoarthritis, and will be administered by ... of Healthpointe. Supartz is an injection of made from ... a natural substance found in joint cartilage. Also known ...
(Date:5/29/2015)... Metamora, Michigan (PRWEB) May 29, 2015 ... region and can cause significant physical, sexual, and psychological ... life altering disorder of Vulvodynia. The actual diagnosis is ... Excellence in Endometriosis, they realize that this problem can ... is experiencing any of these symptoms, they need to ...
(Date:5/29/2015)... The popular all-natural supplement brand, Liporidex, ... Select Program that gives bonuses to members for their ... 100 members per year, lucky members who are selected ... fitness experts at Nuretix Research, and get exclusive benefits ... they attain and maintain their weight loss and fitness ...
Breaking Medicine News(10 mins):Health News:Growth of Data Integration Platform CloverETL Continues in North America 2Health News:Dr. Paul Vitenas Presents at 2015 Aesthetic Meeting 2Health News:Dr. Paul Vitenas Presents at 2015 Aesthetic Meeting 3Health News:Healthpointe is Now Offering Supartz Joint Fluid Therapy at their Anaheim Clinic and La Mirada Clinic. 2Health News:Liporidex, a Sports Nutrition Supplement Brand, Is Searching For Members For Their Exclusive L-Style Select Program Which Rewards Members For Their Achievements 2
... comes a new study that links breakdown of myelin ... of California, Los Angeles (UCLA) researchers showed that genetic ... breakdown, may prove useful in assessing treatments for prevention ... a process uniquely built up in humans, arguably is ...
... The New Women's Health Initiative (WHI) suggests, a prolonged ... carbohydrates results in negligible weight gain. // ... postmenopausal women Vis a Vis variations in consumed foods ... advised to reduce the fat consumption to 20% of ...
... body cavity rather than the conventional intravenous route, seems to ... cancer patients, according to a latest study. // ... among American women. In line with the above finding, the ... all ovarian cancer patients. ,This new treatment modality ...
... help in slowing down the progress of Alzheimer's disease, ... and Chile. The healthy brain // ... their study, to be published in the American Chemical ... surgery, has the potential to destroy beta-amyloid fibrils and ...
... Rotateq and Rotarix in more than 1, 30, 000 ... The vaccines have been found to be 98% and ... 1/3rd of all hospital infections worldwide. ,A ... 1990’s. This however, was withdrawn from the market owing ...
... A leaflet claiming that traditional Chinese medicine was safer ... code in the UK, an industry watchdog said on ... essential treatment from qualified doctors for serious medical conditions, ... produced by Ever Well Ltd, also claimed that serious ...
Cached Medicine News:Health News:Death Risk Of Ovarian Cancer Reduced By Intraperitoneal Chemotherapy 2Health News:Diarrhea Vaccine Trials Promises Prevention of Rotavirus Infection 2Health News:Chinese medicine leaflet broke advertising code 2
Each handle is designed to fit a specific trephine size....
Each handle is designed to fit a specific trephine size....
Each handle is designed to fit a specific trephine size....
Each handle is designed to fit a specific trephine size....
Medicine Products: