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Australia registers leukaemia drug in benefit scheme

02 November 2015 | Regulatory | By BioSpectrum Bureau

Australia registers leukaemia drug in benefit scheme

TGA has registered oral drug, Iclusig, in patient benefit scheme

TGA has registered oral drug, Iclusig, in patient benefit scheme

Singapore: A treatment for patients with chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant or intolerant to current therapies is listed on the Australian Pharmaceutical Benefits Scheme (PBS) from November 1, 2015.

Therapeutics Goods Administration (TGA) registered oral drug, Iclusig (ponatinib), is a new treatment option for adult patients with:

• Chronic phase, accelerated phase, or blast phase CML whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a T315I mutation.
• Ph+ ALL whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a T315I mutation.1

Over 100 patients a year in Australia are now expected to access the potentially life saving treatment via the PBS.

The drug is made available in Australia by biopharmaceutical company Specialised Therapeutics Australia (STA) under license from ARIAD Pharmaceuticals.

Mr Carlo Montagner, chief executive officer, STA welcomed the decision by the Pharmaceutical Benefits Advisory Committee (PBAC) and said it was a great step forward for this group of leukaemia patients for whom other treatments had failed.

 

"We are very pleased that Australian patients with resistant disease will now have equitable access to Iclusig which has been shown to deliver deep and durable responses," he said.


"Previously when patients developed resistance to current available therapies or developed the T315I mutation we had to consider embarking on an allogeneic stem cell transplant which is a high risk procedure in this patient group, or take a palliative approach," Professor Tim Hughes, Beat Cancer Professor at the University of Adelaide and Cancer Theme Leader at SAHMRI (South Australian Health and Medical Research Institute).

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