US FDA approves additional medical indication for Bristol-Myers Squibb's Sprycel; clears Sunovion's Latuda; further delays Vivus' Qnexa

The US Food and Drug Administration yesterday approved a new indication for drug major Bristol-Myers Squibb’s (NYSE: BMY) 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.

Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells.

In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Swiss drug major Novartis’ Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the treatment’s safety and effectiveness. The drug generated sales of $144 million (up 35% on the like 2009 period) for B-MS in its current indication in the third quarter of this year (The Pharma Letter October 27).