U.S. Food and Drug Administration
FDA Approves SPRYCEL(R) dasatinib as Treatment for Adult Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia in Chronic Phase
Published in Medical Letter on the CDC and FDA, November 14th, 2010
After receiving a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The trial is ongoing and further data will be required to determine long-term outcome.
The approval was based on results from the DASISION (Dasatinib versus Imatinib Study in Treatment-Naive CP-CML Patients) open-label, Phase 3 trial, which were published in the New England Journal of Medicine and presented as...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA
More Articles from Medical Letter on the CDC and FDA
- U.S. Food and Drug Administration
Achoo! New help for kids suffering colds? Canadian researchers launch rare trial - Influenza A Virus, Subtype H1N1
Data from Rhode Island Hospital provide new insights into influenza a virus, subtype h1n1 - Attention Deficit Hyperactivity Disorders
Data on attention deficit hyperactivity disorders described by V.J. Muir et al - Bacterial Pneumonia
Data on bacterial pneumonia described by researchers at Winthrop University - Imatinib Therapy
Findings from J.L. Rubin and co-researchers advance knowledge in imatinib therapy - Thrombosis
Harvard Clinical Research Institute Expands DAPT Study into Australia and New Zealand - More from this issue of Medical Letter on the CDC and FDA
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
