ZURICH--The European Medicines Agency Friday recommended Novartis AG's (NVS) cancer drug Afinitor for approval in the European Union for the treatment of advanced breast cancer, supporting the Swiss company's hopes that the drug may become a blockbuster as it wins approval for use in different types of cancer.
Novartis said the EMA's Committee for Medicinal Products for Human Use is backing the use of Afinitor tablets, in combination with hormone therapy, to treat advanced forms of breast cancer in certain women. The Basel-based company said it is submitting the drug for approval worldwide for a certain type of advanced breast cancer. If granted, this will be the fifth indication for Afinitor, which is already approved to treat kidney cancer, as well as certain kinds of brain and pancreatic tumors.
Such extensions of the drug's therapeutic indications are likely to pave the way for Afinitor to become a best-seller thanks to its potential in various types of cancer.
In April, the U.S. Food & Drug Administration granted wider approval to Afinitor, whose generic name is everolimus, to treat non-cancerous kidney tumors that don't require immediate surgery, after the drug was approved in the U.S. in 2009 to treat kidney cancer after treatment with other drugs failed.
Afinitor, a pill taken once daily, blocks the uncontrolled activity of a protein called mTOR, which plays a role in the development and growth of certain tumors.
EMA's nod is based on data from a late-stage trial involving 724 patients with HR+/HER2- advanced breast cancer, which affects an estimated 220,000 women globally each year. The study found that Afinitor combined with hormonal therapy increased the time it took cancer to progress to over seven months, compared with about three months using hormonal therapy alone.
Novartis said the European Commission generally follows CHMP's recommendations and is expected to make a decision within three months.
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