Trastuzumab approved for primary breast cancer.(Regulatory Action and News)

New Zealand--Trastuzumab (Herceptin[R]) has been provisionally approved for the treatment of some women with early stage breast cancer by Medsafe, the Medicines and Medical Devices Safety Authority. Medsafe is the first medicines regulatory authority to assess and approve Herceptin[R] as a treatment for primary breast cancer. Provisional consent limits the use of trastuzumab to treating women with early breast cancer who test positive for the HER2 gene once they have had surgery and completed adjuvant chemotherapy.

Due to concerns that use of trastuzumab may be associated with heart damage, the provisional consent also limits the treatment to those women who have a …