Chronic myeloid leukemia (CML) is a rare cancer characterized by the uncontrolled growth of white blood cells. For the (new oral) treatment of this condition that affects about 4,600 people in the United Sates, Bristol-Myers Squibb’s Sprycel (dasatinib) has been granted accelerated approval by the USFDA.
Sprycel was also given regular FDA approval as treatment in adults who have Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), a more serious form of leukemia.
Sprycel is intended for CML patients who are not responding anymore to, or who can no longer tolerate therapy with Gleevec (imatinib), a drug approved in 2001 for this life-threatening disease.
Read the full FDA News and the BMS press release."Sprycel offers an important alternative for patients with Ph + ALL whose disease has not responded to or has stopped responding to other therapies," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.
"Although the long term benefits of Sprycel in CML are not yet known, early studies have suggested that Sprycel may offer a significant improvement for many patients whose disease is resistant to other therapies; however, further data from ongoing studies are needed to evaluate whether Sprycel provides an actual clinical benefit in CML."
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