FDA gives rapid approval to BMS leukaemia treatment

The US Food and Drug Administration (FDA) has granted accelerated approval for Sprycel (dasatinib), a new oral treatment for patients with chronic myeloid leukemia (CML), a rare cancer characterized by the uncontrolled growth of white blood cells.

CML affects about 4,600 people annually in the US. In addition, the FDA gave regular approval to Sprycel for use in the treatment of adults who have Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), a more serious form of leukemia. Both approvals are for patients who have experienced resistance or intolerance to prior therapy.

Sprycel is manufactured by Bristol-Myers Squibb Company, Princeton, New Jersey, US.

Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research said: "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."

Sprycel, is considered an orphan drug for each of these indications.