Bristol-Myers Squibb is celebrating the news that the European Commission has given the green light to Yervoy, the first late-stage melanoma drug to be approved in the continent in more than two decades.
Specifically, Yervoy (ipilimumab) has been given the thumbs-up for the treatment of adults with previously-treated advanced melanoma. The approval is based on Phase III data which demonstrated one and two-year estimated survival rates for patients on the B-MS drug were 46% and 24% respectively versus 25% and 14% in the comparator arm, with some patients alive for a couple of years after that.
The company quoted Alexander Eggermont of the Institut Gustave Roussy in Paris, who said that with the approval of Yervoy, physicians now have an important new option to offer to patients with metastatic melanoma. "This is a chance of not just months but potentially three to four years of prolonged survival for some patients," he added.
Prof Eggermont went on to say that “there is hope that YERVOY’s novel mode of action", together with the fact that the recommended complete course of treatment includes four infusions over three months, "could potentially change the way we treat patients with previously treated advanced melanoma". He concluded that "it is an example of what can be done through unleashing the power of one’s own immune response".
Ron Cooper, president of B-MS Europe, stated that with an average survival time on diagnosis of six-nine months, "patients with advanced melanoma have had little hope - until now". The firm got hold of Yervoy when it acquired Medarex in 2009 and he said "we will continue this strategy to seek and establish collaborations with other leading innovators across the globe".
Yervoy does not come cheap and in the USA, where it was approved in March, it costs about $30,000 a dose, or $120,000 for the full treatment regimen. B-MS said it will now work closely with local health authorities across the European Union, saying it remains committed to helping ensure that appropriate patients get Yervoy "while the reimbursement process is finalised by the relevant authorities throughout Europe".