Drugmaker Prepares to Ship New Melanoma Drug

Bristol-Myers Squibb plans to start rolling out its newly approved melanoma drug ipilimumab (Yervoy) in the next several weeks, along with extensive educational materials for oncology professionals that include webcasts with key researchers.

The drug, which the FDA approved last week, represents a milestone in using immunotherapy in cancer treatment and clinicians likely will need further education to learn how it works, experts have said. It is the first therapy that has demonstrated improved survival in patients with advanced melanoma.

“It targets the immune system, not the tumor directly, and as such the side effect profile is related to that mechanism of action,” said Axel Hoos, MD, PhD, medical lead for Yervoy at Bristol-Myers and co-chair of the executive committee of the Cancer Immunotherapy Consortium, in an interview with OncLive.

As a result of the adverse events associated with the drug, the FDA is requiring a risk management strategy in which physician education is a key component. Hoos said the material is aimed at helping oncologists manage any adverse reactions.

The prescribing information carries a boxed warning about the potential for “severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation,” with the most common including enterocolitis, hepatitis, dermatitis, neuropathy, and endocrinopathy.

Additionally, the drug works differently than standard chemotherapy and positive impact may not be evident immediately. “We believe the most important benefit coming from the drug is actually not necessarily on response but on survival,” Hoos said.

Ipilimumab is a monoclonal antibody that blocks the cytotoxic T-lymphocyte antigen (CTLA-4) molecule, which researchers suspect slows the body’s immune system.

It is administered intravenously, with a complete course of treatment consisting of 4 infusions of 3 mg/kg doses during a 3-month period at a cost of $30,000 per infusion, or $120,000 for the series. It is indicated for the treatment of unresectable or metastatic melanoma.

Information about Yervoy for health professionals can be found at http://www.yervoy.com/hcp/index.aspx.