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Novartis announced today the US regulatory approval of Femara(R) (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting). The US approval was based on results of the Breast International Group (BIG 1-98) study, which were published for the first time in the December 29 issue of The New England Journal of Medicine (NEJM). BIG 1-98 compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery (adjuvant setting) in postmenopausal women with hormone- sensitive early breast cancer. The study included an analysis of disease-free survival in patients treated for a median of 24 months and followed for a median of 26 months. The BIG 1-98 study is ongoing, and further analyses on safety and efficacy are planned. Femara reduced the risk of breast cancer returning by an additional 21% (p=0.002) over the reduction offered by tamoxifen. Further, patients taking Femara showed a 27% (p=0.0012) reduction in the risk of the cancer spreading to distant parts of the body. While no survival advantage has been demonstrated, this is clinically relevant because women whose disease does spread to other sites (metastases) may be at greater risk of dying from their disease. In addition to the overall findings, Femara demonstrated its greatest benefit in two groups of women at increased risk of recurrence. Femara reduced this risk by 29% in women whose breast cancer had already spread to the lymph nodes at the time of diagnosis and by 30% in women who had undergone chemotherapy. The data also showed that in these high-risk subgroups, Femara reduced the risk of cancer spreading to distant parts of the body by 33% and 31%, respectively.
The approval of Femara for adjuvant use in the US was based on a six-month priority review. The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the diagnosis, treatment or prevention of disease, increased compliance or demonstrated efficacy in subgroups. Novartis recently received approval for this indication in the UK. Femara has also been submitted in the EU, Japan, and other countries. Additional approvals in other countries are expected in 2006.
Five Important Advances in Nanotech
Technology Review picks five important advances in nanotechnology and materials science in 2005 -- and one policy issue that could decide the future of the entire field.
1) Harvesting Energy from the Sun
2) The Lithium Economy
3) Toward Self-Assembling Devices
4) Nanomedicine and
5) Universal Memory
Nanotechnology is leaping technical hurdles -- but ultimately its success will depend on winning over consumers. And that will mean assuring the public that nano-scale materials are safe.
See for more: http://www.technologyreview.com/NanoTech/wtr_16096,318,p1.html
The Year 2005 in Biology and Medicine
Major breakthroughs in 2005 included the publishing of several complete genomes, including a dog called Tasha, the chimpanzee, three human parasites, ancient cave bears, as well as a map of genetic variations called SNPs in the human genome. The year also saw the world’s first human face transplant by French surgeons – one of several international teams vying to achieve this high-profile goal. Visit for more: http://www.newscientist.com/article.ns?id=dn8512
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
One World One Family