The FDA on Friday approved Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of patients with late-stage melanoma. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment," noted Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
FDA spokeswoman Erica Jefferson said the agency authorised the antibody for use in patients with late-stage melanoma who have not received prior treatment, as well as for those who had taken other treatments. The approval was based on results of a clinical trial that randomised 676 patients with melanoma who had stopped responding to other commonly used melanoma treatments and who were not eligible for surgery to receive Yervoy in combination with the experimental cancer vaccine gp100, Yervoy alone, or gp100 alone. Data showed that those who received Yervoy, either in combination with the vaccine or alone, lived an average of about 10 months, while those who received only gp100 lived an average of 6.5 months.
The agency noted that "due to the unusual and severe side effects" associated with Yervoy treatment, some of which proved fatal in the study, Bristol-Myers Squibb is required to implement a plan to inform doctors and patients of the drug’s risks.
Sanford C. Bernstein analyst Tim Anderson remarked that "ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer." He suggested that the therapy could garner sales of $1.7 billion by 2015, representing about 10 percent of the company's total sales. Bristol-Myers Squibb said it would provide details on the price of Yervoy at a later date, although Anderson suggested the agent could cost around $100 000 per year.
Earlier this month, the company reported data from a new trial that demonstrated that Yervoy improved survival in patients with metastatic melanoma who had not received prior treatment. Bristol-Myers Squibb is also evaluating ipilimumab in late-stage trials involving patients with advanced prostate cancer and also plans this year to launch a Phase III trial in patients with lung cancer.
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