Novartis' Tasigna shows efficacy in Glivec-resistant Ph+ CML patients

Swiss drug major Novartis says that data from a Phase II trial of its developmental anticancer agent Tasigna (nilotinib) demonstrate its efficacy in the treatment of blood cancer sufferers who have become resistant to Glivec/ Gleevec (imatinib). The results showed that the drug reduced the number of Philadelphia chromosome positive (Ph+) white blood cell clones in patients with Ph+ chronic myeloid leukemia.

The findings, which formed the basis of regulatory submissions that Novartis made to both the US Food and Drug Administration and the European Medicines Agency (EMEA) earlier in the year (Marketletter June 26), also indicated that Tasigna eliminated the presence of cells containing the defective chromosome in 51% of Glivec-resistant patients in the chronic phase of the disease, 34% of whom achieved a complete response. The drug also in normalized white blood cell counts, which represents a complete hematologic response, in 74% of this subject group.

Study design