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FDA grants priority review to Sprycel for children with chronic myeloid leukemia
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The FDA granted priority review to dasatinib for the treatment of children with Philadelphia chromosome–positive chronic phase chronic myeloid leukemia, according to the agent’s manufacturer.
Dasatinib (Sprycel, Bristol-Myers Squibb), an oral Bcr-Abl tyrosine kinase inhibitor, already is approved for treatment of adults with newly diagnosed Ph+ CML in chronic phase, as well as adults with chronic phase Ph+ CML who were resistant or intolerant to priority therapy, including imatinib.
The FDA is expected to make a decision on the new indication by Nov. 9.
“[This] 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,” Murdo Gordon, executive vice president and chief commercial officer of Bristol-Myers Squibb, said in a company-issued press release. “Sprycel also has the potential to be the first drug in its class approved for pediatric use with an oral solution.”
The supplemental new drug application for the pediatric indication includes data from CA180-226, a nonrandomized phase 2 trial that includes children with newly diagnosed chronic phase CML, as well as those whose disease was resistant to or intolerant of imatinib.