Medicines and Healthcare products Regulatory Agency ( MHRA ) in the United Kingdom has granted a new indication for Arimidex ( Anastrozole ).
MHRA has acted as the Reference Member State for the European Mutual Recognition Variation Procedure leading to further approvals in five other European countries - Austria, Germany, Italy, Portugal and Spain.
The new indication Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer - will mean that more postmenopausal women whose breast cancer is fuelled by the hormone, estrogen - about 75 per cent of all postmenopausal cases - are now eligible to receive Arimidex after surgery to prevent their disease returning.
Arimidex offers a 26 per cent reduction in the risk of breast cancer coming back compared with Tamoxifen, the gold standard for breast cancer management of 30 years standing.
" It has recently been confirmed that Arimidex offers crucial advantages over Tamoxifen, in terms of enabling patients to stay disease free for longer. However, it is only now, with the new indication that more postmenopausal women with breast cancer may benefit from this drug at the earliest opportunity after breast surgery, said Rob Carpenter, at St Bartholomew's Hospital, London.
The MHRA granted the indication on the basis of data from the ATAC ( Arimidex, Tamoxifen, Alone or in Combination ) trial, the largest breast cancer trial ever conducted.
These data demonstrate that Arimidex reduces the risk of breast cancer recurring anywhere in the body by an additional 26 per cent ( HR =0.74; p=