Nilotinib (Tasigna) can now be prescribed as a first-line option for chronic myeloid leukaemia (CML).
The BCR-ABL tyrosine kinase inhibitor has been approved for the treatment of newly diagnosed Philadelphia-chromosome-positive CML in the chronic phase. In an open-label Phase III study in this setting, patients treated with nilotinib 300mg twice daily showed a significantly higher major molecular response rate (as assessed by levels of circulating BCR-ABL transcripts) than those who received imatinib 400mg twice daily (44.3% vs 22.3%; p<0.0001).
The new indication comes with a new 150mg capsule presentation, to allow dosing at 300mg twice daily. The recommended dose for second-line treatment (in patients resistant to or intolerant of imatinib) remains 400mg twice daily.
Further information: Novartis