Navigation Links
FDA Approves Additional Medical Indication for Sprycel
Date:10/28/2010

SILVER SPRING, Md., Oct. 28 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells.

In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the treatment's safety and effectiveness.

Other FDA-approved drugs to treat various forms of CML include Gleevec, approved in May 2001, and Tasigna (nilotinib), approved in October 2007.

The FDA granted Sprycel a priority review for Ph+ CP-CML.

This is the third drug approved for Ph+ CP-CML under accelerated approval, a process allowing the FDA to approve a drug to treat a serious disease with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. A company is required to collect additional long term efficacy and safety information data confirming the drug's benefit. The accelerated approval program provides earlier patient access to promising new drugs while confirmatory clinical trial
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
2. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
3. FDA Approves Botox to Treat Chronic Migraine
4. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
5. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
6. FDA Approves Combination Contraceptive Containing a Folate
7. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
8. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
9. FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
10. FDA Approves Pediatric Use of Chemical Poisoning Treatment
11. FDA Approves Merz Pharmaceuticals Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Tianyin Pharmaceutical Inc. (NYSE Amex: TPI ), ... sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine ... announced the business and development progress at its Jiangchuan ... the September 2014 JCM application (No. 51268) for the ...
(Date:1/22/2015)... WOODBRIDGE, ON , Jan. 22, 2015 /PRNewswire/ - Pivotal Therapeutics ... company with a focus on Omega-3 therapies for cardiovascular disease ... summary of the Company,s accomplishments in 2014 and its outlook ... Dear Fellow Shareholders, We would like ...
(Date:1/22/2015)... Research and Markets ( http://www.researchandmarkets.com/research/3h534b/infectious ) has ... Market by Product, Application, Technology, End User - Global ... The infectious disease diagnostics market is expected ... million by 2019 from $12,422.8 million in 2014. Increase ...
Breaking Medicine Technology:TPI's JCM Updates on Import Registration for International Clients 2TPI's JCM Updates on Import Registration for International Clients 3TPI's JCM Updates on Import Registration for International Clients 4Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 2Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 3
... 13, 2011 A consortium comprised of funds advised by ... Plan Investment Board ("CPPIB") and the Public Sector Pension Investment ... a definitive agreement to acquire Kinetic Concepts, Inc. (NYSE: ... KCI is a U.S.-based medical device company focused ...
... New Technology Expands Treatment,Options ... to Liver,Cirrhosis . ... President of Market Access and,Reimbursement.   Sequana ... of its ALFApump™ System. Over,the coming months, the company will launch the product in ...
Cached Medicine Technology:Apax Partners, CPPIB and PSP Investments to Acquire Kinetic Concepts, Inc. for $68.50 per Share 2Apax Partners, CPPIB and PSP Investments to Acquire Kinetic Concepts, Inc. for $68.50 per Share 3Apax Partners, CPPIB and PSP Investments to Acquire Kinetic Concepts, Inc. for $68.50 per Share 4Sequana Medical Receives CE Mark Approval for the ALFApump™ System and Adds Key Executive to Team 2Sequana Medical Receives CE Mark Approval for the ALFApump™ System and Adds Key Executive to Team 3
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has recently ... View website of AngelWeddingDress.com to find more details. ... online for a bridal party. AngelWeddingDress offers a variety ... Its maternity wedding dresses are specially designed for 2015. ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Autocarinsurancebest.com has released ... purchasing a commercial auto insurance policy . , Auto ... their vehicles. It is no longer necessary to call an ... are now available online on a single website: http://autocarinsurancebest.com/ ...
(Date:1/22/2015)... Jolla, Calif. (PRWEB) January 22, 2015 ... Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen (R-Modesto) ... for their leadership in advancing biotechnology, biomedical science, ... Bonilla and Olsen each received the “2014 Life ...
(Date:1/22/2015)... EBSCO Information Services (EBSCO) and the ... in an effort to further promote visibility and adoption of ... long made AMA journals available via its subscription services, EBSCO ... Network. , Long known as both a subscription ...
(Date:1/22/2015)... VA (PRWEB) January 22, 2015 Step ... power at the Science Museum of Virginia. Wicked Plants, ... , Wicked Plants unearths 75 poisonous, carnivorous and diabolical ... through each room to uncover the biochemical, physical and ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Wicked Plants are taking over the Science Museum of Virginia 2
... of Texas M. D. Anderson Cancer Center ... Knife (R) Perfexion(TM), an advanced radiosurgery ... lesions in the head in a single session, ... )"Leksell Gamma Knife Perfexion suits our clinical needs," ...
... CUREXO Technology Corporation, pioneer in medical robotics ... orthopaedic applications, which is focused on marketing its ... a premarket notification 510(k) application to the U.S. ... in the U.S. for use of its ROBODOC(R) ...
... Ill., Feb. 25 Abbott today announced the successful ... subsidiary Rainforest Acquisition Inc. to purchase all of the ... (AMO). The tender offer expired at midnight Eastern ... extended.The depositary for the tender offer has advised Abbott ...
... Maine, Feb. 25 Millions of Americans live without ... services provided by non-profit dental clinics become increasingly important. ... of Maine Dental Health for AllTM program is helping ... with an estimated 134,000 additional patient visits since its ...
... Feb. 25 The patent expiry of ... companies confronting intense competition from generics. CEOs ... alternative approaches to maintain the growth of ... )A focus on the market for niche ...
... Solutions, Adds Accomplished Financial Executive to its Senior Management Team ... ... Inc. (ATI) announced that Michael A. Brodeur has joined the company ... development and application of video-based telehealth solutions to advance patient care. ...
Cached Medicine News:Health News:M. D. Anderson Cancer Center Acquires Leksell Gamma Knife Perfexion for Targeted Brain Lesion Treatments 2Health News:M. D. Anderson Cancer Center Acquires Leksell Gamma Knife Perfexion for Targeted Brain Lesion Treatments 3Health News:CUREXO Technology Corporation Announces 510(k) Submission to FDA for Total Knee Arthroplasty Application 2Health News:Abbott Successfully Completes Tender Offer for Shares of Advanced Medical Optics 2Health News:Tom's of Maine Dental Health for All(TM) Program Works With Customers and Retailers to Provide Access to Oral Health Care 2Health News:Tom's of Maine Dental Health for All(TM) Program Works With Customers and Retailers to Provide Access to Oral Health Care 3Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 2Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 3Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 4Health News:American TeleCare, Inc. (ATI) Appoints Michael A. Brodeur as Chief Financial Officer 2Health News:American TeleCare, Inc. (ATI) Appoints Michael A. Brodeur as Chief Financial Officer 3
... system is the lowest profile plate clinically ... integrated lock mechanism, which is designed to ... appreciate the narrow width, which decreases the ... system also offers easy to use instrumentation ...
... supplies, and all patient follow-ups. This allows your ... patient up in your office (analogous to putting ... component, for interpreting the reports PDSHEART provides you. ... full access to your reports 24 hours per ...
... leading provider of Telemedicine monitoring and ... outstanding service commitment to patients and ... transtelephonic testing devices that provide enhanced ... using standard telephone lines. TransMedEx's product ...
... Raytel Cardiac Services is a ... uniquely qualified people, combined with state-of-the-art ... clinical information that supports healthcare professionals ... Cardiac Services uses telecommunications and ECG ...
Medicine Products: