FDA OK's Tasigna for leukemia
Early this summer, the US Food and Drug Administration (FDA) approved the Novartis medicine, Tasigna, for treatment of newly diagnosed patients with chronic myeloid leukemia.
In Sweden alone, about 100 people each year are diagnosed with chronic myeloid leukemia, which means that the white blood cells multiply out of control. Tasigna was found to provide better and quicker effect than Glivec, which has been the standard treatment up until this point. In addition, significantly fewer Swedish patients entered the difficult phase of the disease (blast crisis).
Tasigna (Nilotinib) had previously been approved in Europe for the treatment of patients where there is an insufficient efficacy of Glivec. Data that was collected revealed that patients diagnosed with new diseases have benefited from the treatment, and this discovery paved the way for its American approval. Application for approval of early treatment has also been submitted to the European Medicines Agency.
Tasigna was also found to be effective as a means for inhibiting cancer cells in blood or bone marrow. Preference may be granted to drugs that are considered as major therapeutic gain for patients, and therefore, the FDA gave priority to the application for the approval of Tasigna as first line treatment of newly diagnosed adult patients with chronic myeloid leukemia.
The Phase III study involved 846 Swedish patients recently diagnosed with chronic myeloid leukemia. Treated with either Glivec or Tasigna, these participants resided around the nation in Stockholm, Gothenburg, Uppsala, Lund, Luleň, Sundsvall, Umeň and Írebro.
"The advent of Glivec is a major breakthrough. The preparation has a rapid onset . It looks very promising for the future," reported S÷ren Lehmann, Chief of Hematology at Karolinska University Hospital in Huddinge.