ARIAD Pharmaceuticals, Inc. and Specialised Therapeutics Australia Pty Ltd, today announced the marketing approval of Iclusig (ponatinib) in Australia by the Therapeutic Goods Administration (TGA).

The Australian Product Information for Iclusig states that it is indicated for the treatment of adult patients with:

• Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (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.
• Philadelphia-chromosome positive acute lymphoblastic leukaemia (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 T3151 mutation.

Therapy should be initiated and monitored by a haematologist with expertise in managing adult leukaemia.

“Up to thirty percent of patients with CML become resistant to current therapies, and patients with resistant disease eventually run low on treatment options,” said Professor Timothy Hughes, Consulting Haematologist at the Royal Adelaide Hospital and one of the PACE trial investigators. “Iclusig will be a valuable new therapy for refractory leukaemia patients and treating clinicians in Australia.”

ARIAD submitted its marketing application for Iclusig in the third quarter of 2013 to the Therapeutics Goods Administration (TGA), in Australia. Commercial launch of Iclusig is expected to occur early in 2015.

For more details, go to: http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1992387&highlight=