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news.Millennium Pharmaceuticals has filed a supplemental new drug application with the FDA for Velcade in the treatment of relapsed or refractory mantle cell lymphoma, an aggressive subtype of non-Hodgkin's lymphoma that is not curable.
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Currently, Velcade has been approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. To date, over 33,000 multiple myeloma patients have been treated with Velcade worldwide.
The filing in mantle cell lymphoma (MCL) is based on final data from a phase II trial which showed a 33% overall response rate and an 8% complete response rate. Importantly, the median duration of response was 9.2 months; 13.5 months in patients achieving a complete response. These results are similar to four other phase II clinical trials that recorded overall response rates of 30% to 40% with single-agent Velcade.
“This is a significant milestone for the company and highlights the potential of Velcade to treat a very aggressive cancer that does not currently have a standard of care,” said Dr Deborah Dunsire, president and CEO, Millennium.
Earlier this year, Millennium and co-development partner, Johnson & Johnson Pharmaceutical R&D, initiated a phase III clinical trial with Velcade in combination with rituximab in patients with relapsed or refractory follicular lymphoma.