Launch of Highly Targeted Cancer Treatment Tasigna(R) (nilotinib) Offers Potential Lifeline to Ph+ CML Patients Intolerant or Resistant to Existing Therapies, Including Glivec(R) (imatinib)

Tuesday, May 20, 2008 General News
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FRIMLEY, England, May 20

- Tasigna(R) (nilotinib) Effective in 77% of Patients Resistant orIntolerant to Prior Treatment in the Chronic (Early) Phase of Chronic MyeloidLeukaemia (CML)(1)

- Highly Targeted Nature of Tasigna(R) Tackles the Root Cause of CMLWhilst Providing an Acceptable Tolerability Profile for Patients(1)(2)

- Tasigna Expands CML Portfolio for Novartis, Providing EffectiveTreatment Options for the Majority of Patients With Tasigna(R) and the CMLGold-Standard, Glivec(R)(imatinib)

Tasigna(R) (nilotinib) is now available in the UK as a new option totreat adult patients who are intolerant or resistant to previous therapiesfor Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML).The availability of Tasigna(R) means that the majority of patients with CMLcan now be effectively treated, even those who did not respond to or cannottolerate previous therapies including Glivec(R) (imatinib).

Data that led to the European approval of Tasigna(R) show that 77% ofpatients who had no haematological response when they started takingTasigna(R) achieved a complete haematological response with the drug (ie.blood cell counts returned to normal)(1); Furthermore 40% of patientsachieved a complete cytogenic response(1) (meaning that no abnormalchromosomes, the root cause of CML, are detected in the bone marrowcells)(1). At 12 months the overall survival rate was 95%(1).

Based on the success of the current gold standard treatment for CML,Glivec(R) (imatinib), also made by Novartis, scientists developed Tasigna(R)to more specifically target the cause of CML (Bcr-Abl). Other newertreatments for CML have a broad mechanism of action which can lead toincreased side effects. The highly targeted nature of Tasigna(R) means thatit has a positive tolerability profile(2) and few patients who suffered sideeffects from other therapies suffered the same significant side effects withTasigna(R)(2).

Tasigna(R) works quickly in patients who have undergone other therapies,laboratory trials have shown it is effective in 32 out of 33 known imatinibresistant mutant cell lines.(3)

Tasigna trialist, Professor Richard Clark, Consultant Haematologist atRoyal Liverpool University Hospital said:

"Running out of treatment options is a terrible scenario for any patientwith CML, a disease where the prognosis has not always been good. The arrivalof Tasigna(R) is a major step forward for those patients that do not respondto existing treatments. To be able to offer patients a reliable and effectiveoption with a good safety profile is a significant advance in the treatmentof CML."

CML is one of the four most common leukaemias in the world affecting 4000people in the UK(4) Most people with CML can be treated in the long term withGlivec (imatinib) but a small amount of people, estimated at 3% per yearcannot take Glivec(R) because of intolerance or because their cancer mutatesand becomes resistant to Glivec(R)(5) Tasigna(R) offers an effective and welltolerated treatment option to the majority of people with imatinib resistantCML.

Sandy Craine, CML Support UK, welcomes the launch of Tasigna:

"Tasigna is an important advance as it provides an effective treatmentoption for the small number of CML patients who develop resistance to or areintolerant of Glivec. Glivec signified a revolution in the way we think abouttreating cancers and has proven to be very effective in the long term.Tasigna offers patients resistant or intolerant to previous therapies thechance to regain control of their health and continue to live normal andproductive lives."


(1). Kantarjian, H et al. Nilotinib is Highly Active and Safe in ChronicPhase Chronic Myelogenous Leukemia (CML-CP) Patients with Imatinib-resistanceor Intolerance. Oral Presentation. American Society of Hematology AnnualMeeti

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