Bristol-Myers Squibb announced that regulators in Europe and Australia approved Yervoy (ipilimumab) for the treatment of adults with previously-treated advanced melanoma. The drugmaker noted that the immunotherapy, which was cleared in the US earlier this year, is the "first and only approved therapy for pre-treated unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival."
The decision by regulators was based on results of a late-stage trial released last year. Data showed that the one- and two-year estimated survival rates for patients who received Yervoy were 46 percent and 24 percent, respectively, compared with 25 percent and 14 percent among patients given the experimental cancer vaccine gp100, the company noted.
In Europe, where the European Medicines Agency's Committee for Medicinal Products for Human Use had previously issued a positive recommendation on the drug in Europe, the drugmaker indicated that it will work with health authorities to expedite the availability of the drug.
"With an average survival time on diagnosis of six to nine months, patients with advanced melanoma have had little hope," remarked Ron Cooper, Bristol-Myers Squibb's European president. The European approval "is a milestone for patients with advanced disease and is the first outcome of Bristol-Myers Squibb’s commitment to immuno-oncology," Cooper added.
In Australia, the drug, which will be sold as Elroy, was approved for use in patients with previously treated or inoperable melanoma, which was the same study population used in the late-stage trial. While a separate study published in June showed similar improved survival rates for patients with newly diagnosed advanced melanoma, Bristol-Myers Squibb would be required to present more data to the Therapeutic Goods Association proving that the drug is safe in the broader patient population.
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