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 trials are being conducted.

"These drugs have dramatically changed the lives of patients with CML," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease."

In CML, too many blood stem cells develop into a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. These cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or unexpected bleeding may occur.

One open-label, randomized clinical trial in patients with CP-CML evaluated the safety and effectiveness of Sprycel. The trial measured complete cytogenetic response (CCyR) and cytogenetic response (MCyR), gene-based indicators of how well the malignant cells respond to the treatment. The most commonly reported side effects of Sprycel included decreased bone marrow activity resulting in fewer red and white blood cells and platelets (myelosuppression), fluid retention, diarrhea, headache, musculoskeletal pain, and rash.

Sprycel is marketed by New York City-based Bristol-Myers Squibb. Tasigna and Gleevec are marketed by East Hanover, N.J.-based Novartis Pharmaceuticals.

For more information:

FDA: Fast Track, Accelerated Approval and Priority Review Accelerating Availability of New Drugs for Patients with Serious Diseases

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

FDA: Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

National Cancer Institute: Chronic Myeloid Leukemia  

http://www.cancer.gov/cancertopics/pdq/treatment/CML/Patient

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


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

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:3/24/2017)... 24, 2017 The Board of Directors of ... Report 2016 including the complete 2016 Annual Accounts with notes. ... Nordic Nanovector,s website in the section Investor Relations/Reports and presentations/Annual ... ... Kvåle, Chief Financial Officer Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com ...
(Date:3/23/2017)... Research and Markets has announced the addition ... Replacement Procedure By Technique, Repair Procedure By Technique, By Region, By ... ... forecasted to grow at a CAGR of 13.35% during 2016-2021 ... rising aging population, growth in population with heart disease and rising ...
(Date:3/23/2017)... , March 23, 2017 As ... years along with the prevalence of allergic diseases, ... measures are currently revolutionising the ways in which ... Allergies 2017 promises to be both a ... amongst the allergy interest groups, immunologists, research scholars ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... Vighter established its NAEMT ... by providing Prehospital Trauma Life Support (PHTLS) course scholarships to four medics assigned ... education developed in cooperation with the American College of Surgeons to promote critical ...
(Date:3/24/2017)... ... March 24, 2017 , ... The Radiology Business Management Association (RBMA) ... annual awards, now in their 12th year, are among the most prestigious in radiology ... 2016, the awards were retooled to recognize achievements in both large budget (over $5,000) ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... and related services to families and business owners across eastern Michigan, is connecting ... regional families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... that they are now offering treatments for sleep apnea and TMJ at their ... Sleep apnea , specifically the obstructive type, is increasingly being treated at ...
(Date:3/24/2017)... ... March 24, 2017 , ... Gastro Health (“GH”) ... prep patients for colonoscopy at the HyGIeaCare® Center that is to be located ... , The HyGIeaCare® Prep, cleared by the U.S. Food and Drug ...
Breaking Medicine News(10 mins):