Ipilimumab for Melanoma Approved in Europe

Zosia Chustecka

July 18, 2011

July 18, 2011 —The innovative immunotherapeutic ipilimumab (Yervoy, Bristol-Myers Squibb) has been approved by the European Commission for use in adult patients with previously treated melanoma. The drug was approved in the United States in March 2011, also for second-line use.

Ipilimumab offers an "important new option" for patients with metastatic melanoma, said Alexander Eggermont, general director at the Institut Gustave Roussy, Paris, France. The average survival time for such patients is around 6 to 9 months after diagnosis, but this drug offers a "chance of not just months but potentially 3 to 4 years of prolonged survival for some patients," he said in a statement.

Dr. Eggermont was referring to the pivotal clinical trial (N Engl J Med. 2010;363:711-723) that led to the drug's approval, which he was not involved with. In that 676-patient study, ipilimumab was used in combination with a peptide vaccine (glycoprotein), and was compared with the peptide vaccine used alone. The results showed an estimated survival rate of 46% with ipilimumab (compared with 24% for the comparator group) at 1 year, and survival rates of 25% and 14%, respectively, at 2 years. Some patients were still alive at 3 to 4 years.

Ipilimumab has a novel mechanism of action, as previously reported by Medscape Medical News. It is directed against an antigen found on the surface of T cells, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). This antigen acts as a brake on the T cell, but the drug blocks this brake, allowing the T cell to go into attack mode and kill cancer cells, explained study author Stephen O'Day, MD, from the University of Southern California Keck School of Medicine in Los Angeles.

"There is hope that this novel mode of action, together with the fact that the recommended complete course of treatment includes 4 infusions over 3 months, could potentially change the way that we treat patients with previously treated advanced melanoma," said Dr. Eggermont.

Bristol-Myers Squibb reports that it "will now work closely with local health authorities to expedite the availability" of the product.

A sticking point in many European markets is likely to be the high price of the drug — in the United States, it costs $120,000 for the complete course of 4 infusions.

While awaiting approval, the company has been providing the drug in compassionate use and named patient programs to nearly 3000 patients in the European Union. Bristol-Myers Squibb reports that it remains committed to helping ensure that appropriate patients who need ipilimumab will receive it while the reimbursement process is finalized by the relevant authorities throughout Europe.

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