Novartis gets US FDA approval for new Tasigna indication; agency panel backs HRA Pharma's ulipristal

Following a priority review, the US Food and Drug Administration yesterday approved a new indication for Swiss drug major Novartis' Tasigna (nilotinib) 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.

With this approval, Tasigna becomes the first new therapeutic option for newly-diagnosed patients since the introduction of Novartis' Glivec (imatinib), providing a major advance for patients with this blood cancer, the company said.

Tasigna is believed to work by blocking a signal that leads to leukemic cell development. The new indication expands the use of Tasigna to adult patients in earlier stages of the disease. The FDA originally approved Tasigna in October 2007 for the treatment of Ph+CP-CML in adult patients whose disease had progressed or who could not tolerate other therapies, including Gleevec (imatinib), and the drug generated sales of $212 million last year.