Arzerra® (ofatumumab) registered in Australia for first-line use in chronic lymphocytic leukaemia (CLL)
03 October 2014
Arzerra® (ofatumumab) registered in Australia for first-line use in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy.
GlaxoSmithKline announced today that the Therapeutic Goods Administration (TGA) has registered Arzerra® (ofatumumab), a human monoclonal antibody, in combination with chlorambucil or bendamustine for the treatment of patients in Australia with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy.1
“We are delighted by the Australian registration of Arzerra, which provides patients and physicians another treatment option in the management of CLL” said Dr. David Crump, Associate Medical Director, GSK.
Chronic lymphocytic leukaemia (CLL) is a type of slow growing leukaemia that affects developing B-lymphocytes (also known as B-cells).2 In 2010, there were 1,095 new cases of CLL in Australia (663 new cases in men and 432 new cases in women), accounting for 0.9 per cent of all new cancers and making it the most common type of leukaemia.3-5
The risk of developing CLL increases with age and about 10% of CLL patients are reported to be younger than 55 years.6
Arzerra should not be used in patients who are hypersensitive to ofatumumab or to any of the excipients. Care should be taken in patients with hepatitis B, those who require immunisations or have a history of heart disease. Infusion reactions, tumour lysis syndrome, progressive multifocal leukoencephalopathy, bowel obstructions and skin reactions have been reported in patients receiving Arzerra. Side effects associated with treatment with Arzerra include infusion reactions, cytopenias (neutropenia, anaemia, febrile neutropenia, thrombocytopenia, leukopenia) and infections (lower respiratory tract infection, including pneumonia, upper respiratory tract infection, sepsis, including neutropenic sepsis and septic shock, herpes virus infection, urinary tract infection).1
For a copy of the Consumer Medicine Information, please visit: www.gsk.com.au/Arzerra
Arzerra is not available on the Pharmaceutical Benefit Scheme (PBS). Arzerra is available through private prescription and through several hospitals in Australia.
In the management of diseases, healthcare professionals in consultation with their patients should consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of each medicine.
The information contained within this media release does not contain all the available information. It does not take the place of talking to healthcare professionals. Please speak to your health care professional for further information about CLL or Arzerra.
For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit:www.gsk.com.au/Arzerra
You can follow GSK on Twitter for more Australian updates @GSK_AU.
1) GlaxoSmithKline. Arzerra Approved Product Information (October 2014)
2) Leukaemia Foundation. Chronic lymphocytic leukaemia (CLL).
http://www.leukaemia.org.au/blood-cancers/leukaemias/chronic-lymphocytic-leukaemia-cll. [Accessed 24 September 2014].
3) Australian Cancer Incidence and Mortality (ACIM) Books – Chronic lymphocytic leukaemia for Australia (ICD10 C91.1) http://www.aihw.gov.au/acim-books/ [Accessed September 2014].
4) Australian Cancer Incidence and Mortality (ACIM) Books – All Cancers combined for Australia (ICD10 C00-C97, D45-46, D47.1, D47.3). http://www.aihw.gov.au/acim-books/ [Accessed September 2014].
5) Cancer Australia. Chronic lymphocytic leukaemia statistics.
http://canceraustralia.gov.au/affected-cancer/cancer-types/leukaemia/chronic-lymphocytic-leukaemia-statistics. [Accessed 23 September 2014.]
6) Eichorst, B et al. Chronic lymphocytic leukemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 22 (Supplement 6): vi50–vi54, 2011.
Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.
GlaxoSmithKline Australia Pty Ltd, PO Box 18095, Melbourne, VIC 8003. ABN 47 100 162 481.
Arzerra® is a registered trademark of the GSK group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
GSK Australia Enquiries or interview requests contact:
Kim Pickworth, Communications Manager Pharmaceuticals
0477 322 431
03 9721 4560