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FDA approves 'more effective' CML drug

Novartis's Tasigna has received approval from the US Food and Drug Administration to treat chronic myeloid leukaemia at an early stage

Novartis's Tasigna (nilotinib) offers superior outcomes in all key efficacy measures in the treatment of newly diagnosed chronic myeloid leukaemia (CML) compared with the current gold standard treatment, Novartis's oral therapy Glivec (imatinib), according to phase III study results published in the New England Journal of Medicine.

Patients in the trial received either nilotinib 300mg twice daily or imatinib 400mg once daily for 12 months. With nilotinib the rate of major molecular response (MMR) improved by 100 per cent compared to imatinib and 80 per cent of patients achieved complete cytogenic response (CCyR) with nilotinib versus 65 per cent with imatinib.

MMR and CCyR are accepted as key therapeutic milestones associated with good long-term patient outcomes, as patients who achieve MMR rarely experience disease progression. Significantly fewer patients progressed to accelerated or blast crisis phase on nilotinib than on imatinib, demonstrating a statistically significant improvement in disease control.

Eighteen month follow-up results of the study were presented at the 46th annual American Society of Clinical Oncology (ASCO) meeting and the 15th Annual European Haematology Association (EHA) meeting. The 18 month follow-up data reinforced the superiority seen at 12 months.

This phase III study was the first global randomised comparison of two oral therapies. In light of the positive results, the US Food and Drug Administration (FDA) has approved Tasigna as a first-line treatment for CML. Leukaemia drug Tasigna had previously only been approved to treat CML after prior treatment with Glivec had failed.

21st June 2010

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