FDA accepts Bristol-Myers' marketing application for Sprycel in children with Ph+ CML under accelerated review, action date November 9
Friday, July 14, 2017
Source: Seeking Alpha
The FDA accepts under Priority Review Bristol-Myers Squibb's (NYSE:BMY) supplemental New Drug Application (sNDA) seeking approval of Sprycel (dasatinib) for the treatment of children with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CML) in addition to a powder for oral suspension formulation. The agency's action date is November 9.
Priority Review status shortens the review clock to six months from the standard 10 months.
The FDA approved Sprycel for use in adults with Ph+ CML who have been previously treated with imatinib (Novartis' GLEEVEC) in 2006. In 2010, the FDA approved it for newly diagnosed adults with chronic phase Ph+ CML.