Novartis says that newly-published data in the New England Journal of Medicine confirms that the company’s Femara is superior to tamoxifen after breast cancer surgery.
Specifically the data reveals that patients with hormone receptor-positive early-stage breast cancer treated after surgery with Femara (letrozole) enjoyed longer disease-free survival and had a reduced risk of developing distant metastases than those on tamoxifen. The 8,000-patient BIG 1-98 study found that those on Femara monotherapy for five years after surgery enjoyed the same levels of DFS as those given sequential treatment with tamoxifen and the Novartis drug.
In addition, Femara monotherapy demonstrated significant long-term improvement of disease-free survival and reduction in risk of distant disease spread compared with tamoxifen. In patients treated with Femara monotherapy, a non-statistically significant relative reduction in the risk of death of 13% versus tamoxifen was observed.
Henning Mouridsen, professor of oncology at Copenhagen University Hospital and one of the BIG 1-98 trial investigators. noted that letrozole is the only aromatase inhibitor versus tamoxifen to demonstrate early and significant reduction in the risk of distant metastases, significant improvements in disease-free survival, “and this suggestion in overall survival benefit in primary breast cancer patients”.
The data should enhance the already-strong sales of Femara which increased 7% in the second quarter to $310 million.
Meantime Novartis has received approval from the US Food and Drug Administration for the multiple sclerosis drug Extavia (interferon beta-1b), its branded version of Bayer’s Betaseron. The Swiss major sees the forthcoming launch as a stepping stone in establishing itself as a player in MS as it continues development of FTY720 (fingolimod), a once-daily oral therapy it hopes to file for approval by the end of the year.
