FDA Calendar

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
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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