UK first to clear Novartis’ Femara as post-op adjuvant treatment

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the use of Novartis’ Femara (letrozole) for use immediately after surgery in post menopausal women treated for early invasive breast cancer.

The MHRA licence approval is ahead of the rest of the Europe and the US.

The results of the BIG1-98 trial, a large study published earlier this year involving over 8,000 women with breast cancer showed that women taking Femara directly after surgery remained cancer free for longer versus those taking tamoxifen.

Data showed that compared to those taking tamoxifen Femara significantly improved disease free survival by 19 per cent in all women taking it and by 29 per cent in high risk women whose cancer had spread to the lymph nodes. It also significantly reduced breast cancer recurrence by 28 per cent in patients who had previously received chemotherapy and reduced overall risk of cancer spreading to other parts of the body by 27 per cent.

“This is an important milestone in the treatment of postmenopausal women with early invasive breast cancer, as it means there is now a wider range of treatment options for women at all stages of the disease,” said Nigel Bundred, professor in Surgical Oncology, Wythenshawe Hospital, Manchester.

Femara is now the first and only aromatase inhibitor (AI) licensed for treatment across the entire breast cancer treatment spectrum – before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.

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