Oral clofarabine demonstrated a response rate of 43% in patients with higher-risk myelodysplastic syndrome, according to the findings of a phase-2 trial.
Researchers assigned 32 patients to clofarabine (Clolar, Genzyme) 40 mg/m2, 30 mg/m2 or 20 mg/m2 daily for five days, followed by courses repeated every four to eight weeks.
Twenty-two patients had intermediate-2 or high-risk disease; nine patients had secondary myelodysplastic...
Updated NCCN Guidelines for AML Include Risk Stratification to Assist in
Treatment Selection
The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Guidelines for Acute Myeloid Leukemia (AML), the most common acute leukemia affecting adults. Noteworthy updates include the incorporation of risk stratification based on white blood cell count, the alternative to use cord blood in allogeneic...
* FDA fails to approve Clolar in elderly adults with AML
* Agency says Genzyme needs to conduct additional trial
* Result was expected; Genzyme's shares up 1.7 percent
BOSTON, Oct 6 (Reuters) - Genzyme Corp said on Tuesday that U.S. regulators will not allow the company to market its leukemia drug Clolar to previously untreated older adults unless it completes an additional clinical trial.
By John Gever, Senior Editor, MedPage Today
Published: August 28, 2009
An application to market clofarabine (Clolar) for treating acute myeloid leukemia (AML) in patients 60 and older has received a cool reception from FDA staff.
The agency's staff review, released in advance of an Oncologic Drugs Advisory Committee meeting next week, was critical of the data submitted by the drug's manufacturer, Genzyme.
Last Updated: 2009-03-02 17:25:16 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In elderly acute myeloid leukemia (AML) patients undergoing autologous stem cell transplantation (ASCT), a conditioning regimen consisting of 2 days of continuous infusion idarubicin at a dose of 20 mg/m²/d followed by 3 days oral or IV busulphan (4mg/kg/d) is safe and has the potential to prolong the duration of complete remission and survival, a study shows.
