Clofarabine

NEW YORK - Genzyme Corp. must collect more data on the leukemia drug Clolar before the Food and Drug Administration will consider expanding the use of the therapy to previously untreated adults with acute myeloid leukemia. Based on...

In this article: Genzyme Corp., Food and Drug Administration, Clolar, Cancer, Leukemia, Acute myeloid leukemia, Acute lymphoblastic leukemia, Cambridge, NEW YORK, and Massachusetts

...biotech drugmaker. Cambridge, Mass.-based Genzyme has asked the Food and Drug Administration to approve its drug Clolar for adults older than 60, who have leukemia but are not healthy enough to undergo chemotherapy. Leukemia is a cancer of...

In this article: Leukemia, Genzyme, Food and Drug Administration, Clolar, Cancer, Washington, Cambridge, and Massachusetts

...for older patients The Food and Drug Administration's oncology panel voted 9-3 that Cambridge, Mass.-based Genzyme did not conduct the necessary study to prove its injectable drug Clolar is safe and effective. The FDA asked Genzyme to...

In this article: Genzyme, Food and Drug Administration, Leukemia, Cancer, Clolar, Washington, Cambridge, and Massachusetts

...VPHM About this author: On Tuesday morning, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 3 against the label expansion of Genzyme's (GENZ) leukemia drug, Clolar, in acute myeloid leukemia (AML). The FDA does not have to...

In this article: Genzyme, Clolar, Revenue, FDA, ViroPharma, TEVA, EU, U.S., and Fabrazyme

...results are expected in 2011. Clofarabine is also being investigated in clinical trials by most of the leading AML experts and major cooperative leukemia investigation groups in the United States and Europe. The CLASSIC II study, discussed...

In this article: FDA, Systemic inflammatory response syndrome, Genzyme Corporation, Thrombocytopenia, Cytarabine, Leukemia, Capillary leak syndrome, and Cancer

...population, children with leukemia. But Genzyme was hoping to grow the market for the drug to include elderly patients when it paid $345 million to get clofarabine through the acquisition of Bioenvision. The drug isn't one of Genzyme's...

In this article: Genzyme, FDA, Leukemia, Cancer, Acute myeloid leukemia, Gaucher's disease, Twitter, and Nasdaq