SprycelTreatment for Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
PRINCETON, N.J., March 7, 2006 -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) for the investigational compound dasatinib. The NDA seeks approval of dasatinib to treat chronic myelogenous leukemia, as well as Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia, in adult patients with resistance or intolerance to prior therapy.
The Company also announced that the dasatinib NDA will be reviewed for accelerated approval and has been granted a priority review. Based on the priority review, the FDA has six months from the submission date of December 28, 2005, or until June 28, 2006, to take action on the NDA.
Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb laboratories.
Source: Bristol-Myers Squibb
Posted: March 2006
- FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase - June 21, 2013
- FDA approves additional medical indication for Sprycel - October 28, 2010
- FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec - May 26, 2009
- FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML - November 9, 2007
- Sprycel Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) - June 28, 2006
- Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib - June 2, 2006
- Bristol-Myers Squibb Submits New Drug Application for Dasatinib - December 28, 2005