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news.Swedish regulators have approved Viragen's Multiferon for the first-line adjuvant treatment of high-risk malignant melanoma following dacarbazine after surgical removal of tumors.
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Approval for Multiferon in sequential combination with dacarbazine was granted based on clinical trial data that demonstrated a statistically significant advantage over untreated controls in terms of survival-without-distant- metastasis and overall survival.
The current approved therapy for high-risk malignant melanoma in Sweden may include recombinant alpha interferon, following resection, for up to 18 months, sometimes in a high-dose regimen. By comparison, two doses of dacarbazine followed by low-dose Multiferon for six months represents a significant reduction in total treatment time and cost.
Viragen’s president and CEO, Charles Rice, said that the company would now seek broader European approval for the drug.
“We are extremely proud that long-term studies have supported the use of Multiferon in this cancer indication, and that our product has been shown to provide significant survival benefits, while also being well tolerated,” stated Orjan Norberg, managing director of ViraNative AB, the Viragen subsidiary which manufactures Multiferon in Umea, Sweden.