FDA Approves Pfizer's Daurismo for Patients With Acute Myeloid Leukemia
22 November 2018 - 5:49AM
Dow Jones News
By Stephen Nakrosis
The U.S. Food and Drug Administration on Wednesday approved
Daurismo, a Pfizer Inc. (PFE) drug, for some patients with acute
myeloid leukemia.
The approval is for Daurismo in combination with low-dose
cytarabine, a type of chemotherapy, to treat newly-diagnosed acute
myeloid leukemia in adults over 75 and others who have other health
conditions or diseases that may preclude more intense
chemotherapy.
The FDA said it granted this application Priority Review
designation and also gave the Orphan Drug designation to Daurismo.
The Orphan Drug Act grants special status to a drug or biological
product to treat rare diseases and conditions upon request of a
sponsor, the FDA said.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 21, 2018 13:34 ET (18:34 GMT)
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