Britain Approves Decapeptyl as Combo Treatment for Early Stage Breast Cancer

Britain Approves Decapeptyl as Combo Treatment for Early Stage Breast Cancer
Britain has approved Ipsen Pharmaceuticals' Decapeptyl (triptorelin) in combination with tamoxifen or an aromatase inhibitor to treat pre-menopausal, early stage breast cancer patients. The approval came from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA). It covers Decapeptyl's use as an adjuvant therapy -- that is, one that improves the effectiveness of other treatments. Fourteen other European regulatory agencies have also approved Decapeptyl's use for early stage breast cancer. The decisions were based on the results of two international clinical trials that assessed Decapeptyl in 5,700 patients across 27 countries. The trials were supported by the International Breast Cancer Study Group (IBCSG). The Phase 3 trials, SOFT (NCT00066690) and TEXT (NCT00066703), evaluated the value of adding Decapeptyl, an ovarian function suppressor, to adjuvant tamoxifen or the aromatase inhibitor Aromasin (exemestane) in pre-menopausal women, compared with the use of tamoxifen alone. Decapeptyl contains the active ingredient triptorelin, a type of medicine known as a gonadorelin analogue. It acts on the pituitary gland in the brain. Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression, combined with hormone therapy using tamoxifen or Aromasin, may fight breast cancer by reducing the production of estrogen. The women in the
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