Hundreds could benefit as treatment registered

Hundreds could benefit as treatment gains registration for new use

News release
Monday, 18 May 2009
For immediate release

Widened access to a leading-edge biotherapy has given hope to hundreds of New Zealanders diagnosed with chronic lymphocytic leukaemia (CLL), a stubbornly incurable form of white blood cell cancer.

Internationally, CLL is the most common type of leukaemia to affect adults [i] accounting for approximately 25-30 per cent of all leukaemias. [ii] More than 140 New Zealanders are diagnosed with CLL each year and approximately 35 will die from the disease. [iii]

Peter Browett, consultant haematologist at Auckland City Hospital and Medical Director of the New Zealand based Leukaemia and Blood Foundation, says the recent Medsafe registration of MabThera® (rituximab) in combination with chemotherapy for patients with previously untreated CLL [iv] comes as good news as traditionally CLL has been a difficult disease to treat.

“MabThera is the first biotherapeutic that, when added to chemotherapy, has been shown to extend disease free survival and the quality of life of patients with previously untreated CLL. Many patients with CLL go through periods of remission and relapse, severely impacting their quality and enjoyment of life.

“This new form of therapy will allow patients to enjoy a longer and more improved quality of life with less chance of relapse or recurrence.”

Leanne Berkahn, also a consultant haematologist at Auckland City Hospital, says the addition of MabThera to chemotherapy as a treatment for CLL is “an important and significant milestone in treatment and will provide benefit to both patients and their families”.

Dr Berkahn says a large-scale clinical trial, has shown MabThera in combination with chemotherapy to be an effective treatment for patients with previously untreated CLL. The results of the CLL8 trial, presented at the prestigious American Society of Hematology (ASH) meeting in San Francisco in November last year, highlighted the effectiveness of MabThera in extending the time patients with CLL lived without progression of their disease.

The CLL8 trial compared patients who had not previously received treatment, and who normally would receive chemotherapy alone, with patients who received MabThera in combination with chemotherapy. [v]

The CLL8 trial showed that the addition of MabThera increased the number of patients entering complete remission and significantly extended the length of time until disease progression when compared to chemotherapy alone.

Dr Berkahn says large international clinical trials in CLL have included more than 30 New Zealanders from Auckland, Palmerston North, Wellington and Christchurch.

What you should know about MabThera

MabThera® (rituximab) is a Prescription Medicine used to treat chronic lymphocytic leukaemia (a type of blood cancer).

MabThera should not be used if you are pregnant or breastfeeding. Tell your doctor if you have any other health problems including: heart disease, certain blood disorders (e.g. low white blood cells or platelets), hepatitis B, or lung disease, or have had any immunisation recently.

Possible unwanted effects include: Common: fever, chills and severe shivering; nausea; fatigue; headache; runny nose; pain where the lymphoma is located; drop in blood pressure; flushing; pain at site of infusion. Rare (serious): severe skin rash, itching, hives; severe swelling of the face, lips, mouth, throat, hands, feet or ankles; severe shortness of breath, difficulty breathing, wheezing or coughing; frequent infections; numbness of the face; severe vision or hearing loss.

Ask your doctor if MabThera is right for you. Use strictly as directed. If symptoms continue or you experience side effects or would like further information please talk to your doctor or pharmacist or visit www.medsafe.govt.nz for the MabThera Consumer Medicine Information. MabThera (100 mg/10 mL and 500 mg/50 mL single use vials) is an unfunded medicine. You will need to pay for this medicine. A prescription charge and normal doctor’s fees apply.

Notes

[i] Macmillan Cancer Support. What is chronic lymphocytic leukaemia? http://www.cancerbackup.org.uk/Cancertype/Leukaemiachroniclymphocytic/General/WhatisCLL.

[ii] Association of Online Cancer Resources. How common is CLL? http://cll.acor.org/cllfaq/answers/5.html.

[iii] Roche data on File (MAB001)

[iv] MabThera® (rituximab) DataSheet. 02 April 2009

[v] Halleck M, Fingerle-Rowson G, Fink A ,Immunochemotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R), (FCR) Versus Fludarabine and Cyclophosphamide (FC) Improves Response Rates and Progression-Free Survival (PFS) of Previously Untreated Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) Blood 2008: 112 (11);125

ENDS

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