The U.S. Food and Drug Administration Monday approved Bristol-Myers Squibb’s supplemental new drug application (sNDA) that allows its existing drug to treat another form of leukemia and add a new powder form of the drug.
Sprycel (ingredient: dasatinib) has been used since 2006 to treat adults who do not have alternative forms of treatment such as Gleevec for a rare disease called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The recent FDA approval allows Sprycel to treat newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), which affected about 5,900 patients in the United States in 2013.
Data from the ongoing Phase 2, open-label, non-randomized clinical trial called CA180-226 proved the efficacy and safety of the drug.
“Today's news reinforces our commitment to addressing the unique and often unmet needs of pediatric oncology patients, including children with newly diagnosed and imatinib intolerant or resistant CML,” said Murdo Gordon, executive vice president and chief commercial officer. “Sprycel also has the potential to be the first drug in its class approved for pediatric use with an oral solution.”
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