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."
ENDS