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PTAC has first view of trastuzumab (herceptin)

16 February 2006

PTAC has first view of trastuzumab for early breast cancer

The Pharmacology and Therapeutics Advisory Committee (PTAC) today examined evidence to support an application to fund trastuzumab (Herceptin) for early breast cancer.

PTAC is a committee of 10 clinicians with expertise in critical appraisal, whose role is to provide clinical advice to PHARMAC on pharmaceuticals being considered for subsidy. Today's meeting was a regular quarterly meeting of the committee, with trastuzumab as one of a number of agenda items.

PHARMAC Medical Director Dr Peter Moodie says PTAC spent considerable time discussing trastuzumab. He says PTAC acknowledges and recognises the concern of women with breast cancer and realises that they want to have access to the drug as soon as reliable data is obtained.

PTAC's view is that the interim and incomplete data provided to it looks promising, but it expressed concerns about the safety profile.

Dr Moodie says PTAC notes that trastuzumab has yet to be registered by the New Zealand medicines regulator Medsafe, or by any other country in the world, for early breast cancer. PTAC's view is that the drug must obtain Medsafe approval before PTAC makes any recommendation, Dr Moodie says.

"The committee will not pre-empt any decision of Medsafe but PTAC does note that there are a number safety issues that need to be addressed," Dr Moodie says. "PTAC recommends that at present for early breast cancer, this is a drug that should only be administered as part of a clinical trial."

"PTAC will continue to treat this as a matter of priority and will review it once Medsafe has made its decision. At that point, it will also be seeking further advice from its cancer treatments sub-committee."


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