European approval for ‘double strength’ Faslodex
pharmafile | March 19, 2010 | News story | Sales and Marketing | AstraZeneca, Faslodex, breast cancer
AstraZeneca’s Faslodex has expanded its European licence after winning approval to treat women with hormone receptor-positive breast cancer in a 500mg dose.
Regulators passed the drug to be used at twice its previously licensed dose of 250mg, persuaded by trial data showing it significantly improved disease control in patients with metastatic breast cancer, without affecting tolerability.
Faslodex (fulvestrant) 500mg is indicated to treat postmenopausal women with hormone receptor-positive metastatic breast cancer whose disease has re-occurred or progressed while on an anti-oestrogen treatment.
The approval was given following the recent positive opinion from the CHMP on data from the phase III CONFIRM study.
The study showed a 20% reduction in the risk of disease progression for patients receiving the 500mg dose of Faslodex when compared with 250mg.
As a result, 34% of patients in the Faslodex 500mg group remained alive and progression-free after one year compared with only 25% of those in the 250mg group.
Dr Angelo Di Leo, CONFIRM’s principal investigator, said: “Fulvestrant 500mg represents a significant improvement in the management of metastatic breast cancer.
“The clinical development programme, which was completed with the recent findings of the CONFIRM study, indicated that the 500mg dose enhances estrogen receptor down-regulation, providing a new, effective option to regain and maintain control over this devastating disease.”
The female hormones oestrogen and progesterone affect the growth of some breast cancers and in the hormone receptor-positive form of the disease they cause the progression of cancerous cells.
The traditional treatment for hormone receptor-positive breast cancer is to use anti-oestrogen treatments such as an aromatase inhibitor or tamoxifen that can be used before or after therapy.
Faslodex works by blocking the action of estrogen at its receptor and disrupting estrogen signaling, leading to ‘down-regulation’ of the estrogen receptors in the tumour as well as disruption of other cancer growth pathways.
This mechanism of action not only reduces the growth and spread of the cancer, but may help to reduce or delay resistance to treatment.
Faslodex was first launched in Europe in 2004 to treat advanced breast cancer in post-menopausal women whose cancer has progressed on previous anti-oestrogen treatments such as tamoxifen.
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