Roche's Kadcyla nails EU approval for treating breast cancer

Roche's Kadcyla, a drug some refer to as a "super Herceptin," has racked up another approval as it rolls toward a forecast of $2.5 billion in sales within 5 years. Wednesday, The European Commission approved the targeted cancer drug for patients with previously treated HER2-positive advanced breast cancer.

More than 70,000 people in Europe are diagnosed each year with advanced breast cancer, and about 20% of those will have HER2-positive disease, Roche ($RHHBY) said. That provides a significant patient pool for a drug that is reportedly priced in the U.S. at $9,800, twice the cost of Roche's wildly successful Herceptin. Roche said patients taking Kadcyla survived almost 6 months longer than on the standard treatment of lapatinib and Xeloda. Kadcyla was approved by the FDA in February.

Roche licenses technology for Kadcyla under an agreement with Waltham, MA-based ImmunoGen, and the EU approval means that company will pick up a $5 million milestone payment, according to The Wall Street Journal

Roche is the global leader in cancer drugs. As WSJ points out, revenues from oncology drugs turned in the biggest piece of Roche's nearly $50 billion in sales last year, and Kadcyla is just one of the Swiss drugmaker's new targeted cancer treatments. Last year the FDA approved Perjeta (pertuzumab) and then in September granted it a historic approval for the treatment of breast cancer before surgery. Roche is studying Kadcyla for the very same use. Herceptin is also approved for breast cancer treatment, as well as a lot of other conditions, but is expected to see competition from biosimilars in the next few years. The drugmaker reported last month that sales of the three drugs were up a combined 13% in its third quarter.

In an effort to gear up for further sales of Kadcyla, Perjeta and other biologics, the drugmaker last month laid out a blueprint for significant expansion of its manufacturing network. It said it would invest 800 million Swiss francs ($881.8 milllion) to build a new facility in Switzerland and expand plants in the U.S. and Germany over the next 5 years, adding nearly 500 jobs in the process.

- here's the announcement
- more from The Wall Street Journal (sub. req.)

Special Report: Top 15 Drug Launch Superstars - Kadcyla - Roche/Genentech

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