Herceptin gets European nod
Genentech seeking FDA approval for broader use of breast cancer drug
NEW YORK (CNNMoney.com) - European health authorities have recommended the approval of Herceptin for a broader use in breast cancer treatment, which might help Genentech get the drug approved for a larger patient population in the U.S.
Herceptin was developed by the South San Francisco-based biotech Genentech (up $0.16 to $79.74, Research), which is majority owned by the Swiss drugmaker Roche, which markets the drug internationally. Herceptin has been on the market for years as a treatment for advanced metastatic breast cancer for women with a specific gene. Some 20 to 30 percent of women carry the HER-2 protein produced by this gene.
Herceptin was approved by the Food and Drug Administrative in 1998 and by European health authorities in 2000 as a late-stage treatment. Since then, sales have grown quickly. U.S. sales for the drug totaled $747 million in 2005 and $290 million in the first quarter of 2006, according to Genentech.
Roche said that the European Union's Committee for Human Medicinal Products recommended Herceptin as a treatment in early-stage breast cancer on Thursday. If this leads to final approval by the European Commission, it could help set up the drug for FDA approval, which could lead to additional sales for Genentech. The biotech applied to the FDA for early-stage use back in February.
Genentech, the world's second largest biotech, beat expectations on April 11 when it announced first quarter earnings of 46 cents per quarter, compared to a consensus projection of 41 cents. Genentech also reported a 39 percent sales jump to $1.6 billion.
To read more about Genentech earnings, click here.