Novartis disappointed by UK's NICE preliminary recommendation on nilotinib

Novartis Oncology, a UK unit of the Swiss drug major, says it disagrees with the National Institute for Health and Clinical Excellence's (NICE) preliminary view that neither its Tasigna (nilotinib) nor dasatinib (Bristol-Myers Squibb's Sprycel) should be recommended for use in the treatment of Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia (CML) patients who are intolerant to imatinib (The Pharma Letter February 9).

The company added that it will work with the NICE to provide and evaluate the evidence to support nilotinib's use in this setting with the aim of overturning this recommendation before a final decision is made.

Nilotinib is indicated for the treatment of adults with chronic phase and accelerated phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Nilotinib is not indicated to treat patients with CML who are in the blast crisis phase of the disease. Most people with CML can be treated with imatinib, however, a small proportion (estimated at 0.7% of patients treated with imatinib each year) are not able to take imatinib (the current gold-standard first-line therapy) because they experience side effects.