European Commission and Australia OK Bristol-Myers Yervoy and Novo Nordisk's FlexTouch

Following a recent positive recommendation from the European Medicine Agency’s advisory panel, Bristol-Myers Squibb today announced that the European Commission has approved US drug major Bristol-Myers Squibb’s (NYSE: BMY) Yervoy (ipilimumab) for the treatment of adult patients with previously-treated advanced melanoma (The Pharma Letter May 23).

Also yesterday, the Australian drug regulator cleared the drug for marketing, under the trade name Elroy, and there it will be offered free to patients until it can be added to the Pharmaceutical Benefits Scheme.

Yervoy, the first European Union-approved therapy for pre-treated unresectable or metastatic melanoma in more than two decades, has already gained approval from the US Food and Drug Administration (TPL March 28), and has projected sales of $2 billion a year at peak. Although B-MS has not indicated European pricing, the drug costs $30,000 per dose, or some $120,000 per treatment course, in the USA.