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news.The FDA has granted priority review designation to Millennium Pharmaceuticals' supplemental new drug application for Velcade for the treatment of relapsed mantle cell lymphoma, an aggressive, incurable subtype of non-Hodgkin's lymphoma for which there is no current standard of care.
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Priority review is granted to a pharmaceutical compound that addresses an unmet medical need and would be a significant improvement in treatment compared to existing therapies. The FDA expedites the approval process for such a supplemental new drug application (sNDA) and aims to come to a decision within six months.
The sNDA submission was based on final phase II data from a trial named PINNACLE, one of the largest multi-center studies in relapsed mantle cell lymphoma to date, which showed a 33% overall response rate and an 8% complete response rate. Importantly, the median duration of response was 9.2 months, and 13.5 months in patients who achieved a complete response.
These results are similar to those of four investigator-initiated phase II clinical trials, in which overall response rates of 30% to 40% with single-agent Velcade were observed.
“Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma,” said Dr Deborah Dunsire, president and CEO of Millennium. “Our mantle cell lymphoma application, for which we can expect a decision from the FDA by December 9, 2006, is the first step in an advanced non-Hodgkin’s lymphoma development program.”