The US Food and Drug Administration (FDA) has said it will review Bristol-Myers Squibb’s investigational compound dasatinib in six months instead of the usual 10, as it could represent a significant advance in the treatment of patients with leukaemia.
B-MS is seeking approval of dasatinib for the treatment of chronic myelogenous leukemia, as well as Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia, in adult patients with resistance or intolerance to prior therapy.
The FDA has set itself a deadline of June 28 to deliver a verdict on the marketing application for dasatanib.
In December, B-MS reported data indicating that dasatinib was effective in CML patients who had failed treatment with Novartis’ blockbuster cancer drug Gleevec/Glivec (imatinib). Novartis’ drug is already approved in this indication as well as a rare form of stomach cancer (gastrointestinal stromal tumours) and racked up sales of $2.2 billion in 2005, up 32% year-on-year.
Dasatanib will compete with Glivec in CML treatment, and could find a ready market in the 30% or more patients who do not respond to Novartis’ drug, according to analysts, who suggest the compound could see peak sales in excess of $500 million.
