Sprycel Third Drug Approved for Ph+ CP-CML under accelerated approval

[Guest guest]

October 29, 2010..................

" The U.S. Food and Drug Administration approved a new indication for Sprycel

(dasatinib) for the treatment of a rare blood cancer when it is first diagnosed.

The cancer, called Philadelphia chromosome positive chronic phase chronic

myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow

disease linked to a genetic abnormality.

" This is the third drug approved for Ph+ CP-CML under accelerated approval, a

process allowing the FDA to approve a drug to treat a serious disease with an

unmet medical need based on an endpoint thought to reasonably predict clinical

benefit. A company is required to collect additional long term efficacy and

safety information data confirming the drug's benefit. The accelerated approval

program provides earlier patient access to promising new drugs while

confirmatory clinical trials are being conducted.

" Sprycel is supplied as a white to off-white, biconvex, film-coated tablet

designed for oral administration. The recommended initial dosing of Sprycel is

70 mg twice daily with or without food. Incremental dose increase or decrease

(in 20 mg steps) is recommended based on individual safety and tolerability.

" These drugs have dramatically changed the lives of patients with CML, " said

Pazdur, M.D., director of the Office of Oncology Drug Products in the

FDA's Center for Drug Evaluation and Research. " Results from additional CML

studies continue to demonstrate the importance of studying cancer drugs in the

earlier stages of a disease. "

http://www.medicalnewstoday.com/articles/206082.php

FYI,

Lottie Duthu