ZURICH European health regulators recommended Roche's breast cancer drug Perjeta for approval on Friday, cementing the company's hopes that the drug will become the standard of care for an aggressive, incurable form of cancer.
Roche is hoping that combining Perjeta with its older drug Herceptin will become the standard treatment for women with a form of cancer known as HER2-positive, which makes up about a quarter of all breast cancers and has no cure.
Breast cancer is the most common cancer among women worldwide, with about 1.4 million new cases diagnosed each year and more than 450,000 women dying of the disease annually, according to the World Health Organization's International Agency for Research on Cancer.
U.S. health regulators already granted the drug approval in June. Recommendations from the European Medicine's Agency (EMA) are normally endorsed by the European Commission within a couple of months.
Perjeta is an effective but costly drug. A typical 18-month course of Perjeta plus Herceptin costing approximately $188,000.
Vontobel analyst Andrew Weiss forecasts peak sales of 2 billion Swiss francs ($2.15 billion) for the drug.
Roche is also developing an "armed antibody" known as TDM-1 as a treatment for HER2-positive breast cancer. TDM-1 combines Herceptin with a derivative of a powerful type of chemotherapy and is designed to reduce unpleasant side effects.
(Reporting by Caroline Copley; Editing by Hans-Juergen Peters)
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