The approval was based on the IBIS-II study in which Anastrozole therapy resulted in fewer cases of breast cancer in women compared to the placebo group
Anastrozole is indicated to be taken as a 1mg tablet, once a day for five years. (Credit: Christina Victoria Craft on Unsplash)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of Anastrozole to prevent breast cancer in women who are at the post-menopausal stage.
Anastrozole is an aromatase inhibitor, which has been indicated to be taken as a 1mg tablet, once a day for five years.
The hormone treatment was previously granted authorisation for use in the treatment of breast cancer in post-menopausal women and has been used off-label for prevention.
The latest approval confirms the indication for prevention in post-menopausal women who are at moderate or high risk of developing the disease.
It was based on the IBIS-II study in which Anastrozole therapy resulted in fewer cases of breast cancer in women compared to the placebo group. It has been shown to lower the risk of the disease by almost 50%.
IBIS-II is a global, randomised double-blind, placebo-controlled trial.
Anastrozole reduces the quantity of oestrogen that a patient’s body produces by inhibiting the aromatase enzyme.
The medication’s most usual side effects include hot flashes, weakness, joint pain or stiffness, arthritis, skin rash, nausea, headaches, osteoporosis, and depression.
The British health regulator will closely review the safety and effectiveness of aromatase inhibitor.
MHRA chief executive Dame Raine said: “This innovative Programme is essential to support and advance research into medicines that might be repurposed, increase access to life-saving medicines and, ultimately, improve patients’ lives.
“The MHRA welcomes applications for repurposed medicines and encourages early dialogue from companies or developers considering this.”
National Health Service (NHS) England anticipates that the drug will help prevent over 2,000 cases of breast cancer in the UK.