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Company Name Bristol-Myers Squibb Co.
Drug Name Sprycel (sNDA)
Event Name FDA decision on Sprycel to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia
Event Date 11/09/2017
Outcome Date 11/10/2017
Outcome FDA expanded approval of Sprycel to include treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) on Nov.10
Drug Status Priority review
Rival Drugs
Market Potential
Other Approvals Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.
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