FDA Accepts For Priority Review Bristol-Myers' SNDA For Sprycel For Children
Monday, July 10, 2017
(RTTNews.com) - Bristol-Myers Squibb Co. ( BMY ) announced Monday that the U.S. Food and Drug Administration accepted its supplemental New Drug Application or sNDA to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase or CP chronic myeloid leukemia or CML, as well as a powder for oral suspension or PFOS formulation of Sprycel.
The application is under priority review with an action date of November 9, 2017.
The sNDA includes data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel inpediatric patients with CP-CML that are resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with CP-CML.
Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers, stated that Sprycel also has the potential to be the first drug in its class approved for pediatric use with an oral solution.
Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase who are resistant or intolerant to prior therapy including imatinib.
Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.
Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. This indication is approved in more than 50 countries.