SILVER SPRING, Md., Oct. 28 /PRNewswire-USNewswire/ — The U.S.
Food and Drug Administration today approved a new indication for
Sprycel (dasatinib) for the treatment of a rare blood cancer when
it is first diagnosed. The cancer, called Philadelphia chromosome
positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a
slowly progressing blood and bone marrow disease linked to a
Sprycel, an oral kinase inhibitor, is believed to inhibit the
activity of certain proteins responsible for the growth of cancer
cells. The action allows bone marrow to begin reproducing normal
red and white blood cells.
In June 2006, the FDA granted accelerated approval for Sprycel
to treat adults with CP-CML with resistant disease or who were
intolerant to prior therapy, including Gleevec (imatinib). The
agency converted Sprycel to a regular approval in May 2009, after
24-month follow-up data from earlier clinical studies confirmed the
treatment’s safety and effectiveness.
Other FDA-approved drugs to treat various forms of CML include
Gleevec, approved in May 2001, and Tasigna (nilotinib), approved in
The FDA granted Sprycel a priority review for Ph+ CP-CML.
This is the third drug approved for Ph+ CP-CML under accelerated
approval, a process allowing the FDA to approve a drug to treat a
serious disease with an unmet medical need based on an endpoint
thought to reasonably predict clinical benefit. A company is
required to collect additional long term efficacy and safety
information data confirming the drug’s benefit. The accelerated
approval program provides earlier patient access to promising new
drugs while confirmatory clinical trial