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FDA Approves 1st Targeted Drug for Certain Leukemia Patients

In patient testing, Rydapt with chemotherapy extended the time before the leukemia worsened or the patient died, compared to chemotherapy alone

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    FDA Approves 1st Targeted Drug for Certain Leukemia Patients
    AP
    This image provided by Novartis shows Rydapt. The Food and Drug Administration on Friday approved Rydapt for treating adults newly diagnosed with acute myeloid leukemia who have a genetic mutation called FLT3. Patients would take it along with chemotherapy. The drug, known chemically as midostaurin, is the first new medicine for acute myeloid leukemia in 25 years, according to the company.

    U.S. regulators have approved the first targeted drug for certain patients with an aggressive form of leukemia.

    The Food and Drug Administration on Friday approved the drug for adults with acute myeloid leukemia who have a genetic mutation called FLT3. Also OK'd was a test to identify those patients. The drug, Rydapt, known chemically as midostaurin, is used along with chemotherapy.

    The drug's maker, Novartis Pharmaceuticals Corp., said it is the first new medicine for the blood cancer in 25 years. It was also approved for three very rare blood disorders.

    In patient testing, Rydapt with chemotherapy extended the time before the leukemia worsened or the patient died, compared to chemotherapy alone.

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    Novartis said the list price will be $14,990 for four weeks of treatment.