www.fdanews.com/articles/101520-tasigna-approved-in-europe
Tasigna Approved in Europe
November 28, 2007
Novartis’ Tasigna has received European Union (EU) approval as a therapy for patients with a form of leukemia resistant or intolerant to prior treatment.
The approval was supported by data showing Tasigna (nilotinib) produced a positive response in 49 percent of patients in the chronic phase of Philadelphia chromosome-positive chronic myeloid leukemia. Most patients achieved this response within three months of starting treatment, according to Novartis.
The decision applies in all EU member states plus Norway and Iceland and follows recent approvals in the U.S. and Switzerland.