Roche’s Skin-Cancer Drug Erivedge Wins EU Agency BackingNaomi Kresge
Roche Holding AG won the backing of a European advisory panel for its skin-cancer medicine Erivedge, a step forward in the Swiss drugmaker’s plan to market the non-surgical, non-radiation treatment for people with advanced forms of the most common type of skin cancer.
Roche should be given conditional approval to sell the drug as a treatment for basal cell carcinoma that has spread or can’t be treated with surgery or radiotherapy, the London-based European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement on its website today. The European Commission usually follows the panel’s advice.
European approval will open up a market in which patients may be easier to reach than in the U.S., said Iris Roth, who is in charge of sales and development strategies for Erivedge. That’s because they’re treated by one group of doctors, so-called dermato-oncologists, while U.S. patients get treatment from both dermatologists and surgeons, Roth said in an interview before the announcement.
“The patients are much more concentrated,” she said. “It’s really hard for us to project patient numbers. This is a disease that has been really unrecognized, very little published about it.”
A pregnancy-prevention plan will be included in the marketing authorization, the EMA said. U.S. regulators required a warning to patients of the risk of death or severe birth defects. Roche, based in Basel, Switzerland, and partner Curis Inc., based in Lexington, Massachusetts, won U.S. approval for Erivedge in January 2012.
The drug had 13 million Swiss francs ($13.8 million) in U.S. sales in the first quarter this year. Erivedge’s wholesale price in the U.S. is $7,900 a month, Roth said, declining to comment on probable European pricing.