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:8/4/2017)... The search for test results that can ... has long been the goal of healthcare providers and ... the largest meeting of lab professionals and IVD firms ... firm Kalorama Information.  The firm said scores of companies ... supplies and software were at the American Association for ...
(Date:8/2/2017)... AURORA, Ore. , Aug. 2, 2017  Life Flight ... Call Agreement. The agreement improves patient care and operational efficiency ... Springfield , Cottage Grove ... ICU level medical transportation. PeaceHealth and Life Flight Network work ... care available during transport, or when a time sensitive emergency ...
(Date:7/31/2017)... , July 31, 2017 7D Surgical, developer of ... has purchased the 7D Surgical System to support its strategic ... Washington D.C. and Virginia.  7D Surgical has entered ... many of the premier medical facilities within those markets. ... ...
Breaking Medicine Technology:
(Date:8/22/2017)... , ... August 22, 2017 , ... “Wilderness Voices”: a ... world travel. “Wilderness Voices” is the creation of published author, Martha McKown, an ... McKown was inspired as a very young child when her older sisters studied High ...
(Date:8/22/2017)... ... 2017 , ... “Glimpses Of Light”: is a unique and thought inspiring ... the creation of published author, J.M. Shepherd, a writer, teacher, traveler, and metaphysician, the ... mysteries. , Shepherd shares, “Love is one of the least understood and yet most ...
(Date:8/22/2017)... (PRWEB) , ... August 22, 2017 , ... “Call Of ... Duty” is the creation of published author, C.S. Lizarde. Growing up on the ... untimely trials. When Carlos began to apply the Biblical keys to his life, ...
(Date:8/21/2017)... ... August 22, 2017 , ... Nanoparticle research provides an exciting ... By learning and implementing best practices for containment using ventilated safety enclosures, many ... gain a better understanding of a method for safely testing nanotechnology hoods. They ...
(Date:8/21/2017)... ... ... FCPX LUT Monochromatic Volume 2 is an all-new Look-Up Table color-grading pack ... to footage. A LUT is a Lookup Table that contains a mathematical formula for ... by the table. This pack comes with 60 different monochromatic CUBE LUT files. , ...
Breaking Medicine News(10 mins):