- Sandoz announces FDA approval, U.S. launch of chemotherapy drug
- New alliance will crack down on adulterated products touting dietary supplement claims
- FDA approves test to monitor levels of Zortress in the bloodstream
- FDA releases annual 'Generic Drug Roundup'
- FDA approves Novartis drug for high blood pressure treatment
SILVER SPRING, Md. The Food and Drug Administration has approved a new usage for a blood cancer drug, the agency said Thursday.
The FDA approved Bristol-Myers Squibb’s Sprycel (dasatinib) for treating chronic phase chronic myeloid leukemia that contains the so-called Philadelphia chromosome, also called Ph+ CP-CML. The FDA originally approved the drug in June 2006 for patients with CP-CML for whom treatment with Novartis’ Gleevec (imatinib) had failed. CML results from an overabundance of blood stem cells developing into abnormal forms of white blood cells called granulocytes, which build up in the blood and bone marrow and crowd out healthy white and red blood cells and platelets, creating risk for infections, anemia and unexpected bleeding.
“These drugs have dramatically changed the lives of patients with CML,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of the disease.”