Switzerland’s Novartis has received a boost following the news that Germany, via the European mutual recognition procedure, has become the first country to grant marketing authorisation for the firm’s anti-cancer agent, Femara (letrozole), as a treatment for postmenopausal women who have completed five years of standard adjuvant (post-surgery) tamoxifen therapy for breast cancer. The approval was based on the landmark MA-17 study of more than 5,100 postmenopausal women, which showed that Femara reduced the risk of cancer recurrence by 42% [[10/10/03b]].
The company noted that, while tamoxifen is beneficial for five years post-surgery, if used beyond that, the risks outweigh the benefits and Femara is the only clinically proven therapy to “effectively address the unmet medical need to reduce the ongoing risk of breast cancer recurrence” following standard treatment.
Diane Young, global head of clinical development at Novartis Oncology, said the firm looks forward to more approvals for this indication throughout the EU in the near future, adding that the availability of Femara “will offer more women the chance to live free of breast cancer recurrence.”
In other news, the Scottish Medicines Consortium, which is the country’s equivalent to England and Wales’ National Institute of Clinical Excellence, has given the go-head for Femara in this new indication, a move welcomed by Dr Dave Cameron, consultant oncologist at the Western General Hospital in Edinburgh, who said it “gives women an even better chance of cure.”
The approval comes just weeks after Novartis revealed data that showed that Femara is more effective than tamoxifen in reducing the overall risk of breast cancer recurrence after diagnosis and surgery [[27/01/05d]], and this latest indication should boost sales of the drug even further beyond its 2004 figure of $386 million dollars [[21/01/05a]].