Roche gets key nod for targeted skin cancer drug en route to EU approval

A standout drug for "personalized" skin cancer treatment has gained a key endorsement from European regulators. Roche ($RHHBY) said that the European Medicines Agency backed the targeted melanoma drug for approval. The Swiss drug giant hopes to secure from the European Commission in February.

The drug--developed by Daiichi Sankyo-owned biotech Plexxikon in Berkeley, CA--is intended to treat the aggressive forms of melanoma in which BRAF gene mutations are found, and Daiichi Sankyo's partner Roche is providing a companion diagnostic that screens patients for the mutation prior to treatment. The FDA approved the drug in August, after giving the market green light to Bristol-Myers Squibb's ($BMY) Yervoy for melanoma. Analysts expect sales of Zelboraf--which costs $56,000 for a six-month course of treatment--to reach nearly $1 billion in sales in 5 years, Reuters reported.

Zelboraf combats the deadliest form of skin cancer, and, unfortunately, one that has been on the rise. Globally, there were 200,000 new cases of melanoma in 2008, up from 160,000 cases in 2002, and the cancer kills about 40,000 people per year, according to figures cited by Roche. With fewer than one in four patients with the cancer expected to live beyond a year, Roche impressed clinicians last year with data that the drug, known generically as vemurafenib, reduced patients risk of dying by 63% during treatment compared to those on standard chemo treatments.

"The (Committee for Medicinal Products for Human Use) recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options," Dr. Hal Barron, Roche's chief medical officer and head, global product development, said in a statement. "We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible."

- here's the release
- read Reuters' coverage