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news.Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company has filed two supplemental new drug applications (sNDAs) with the US Food and Drug Administration (FDA) for Velcade (bortezomib) for injection.
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Currently, Velcade is approved for intravenous use only for the patients who are suffering from multiple myeloma and for patients with mantle cell lymphoma who have received at least one prior therapy, a sub-type of non-Hodgkin lymphoma (NHL).
Millennium’s and Takeda‘s first sNDA is seeking addition of a subcutaneous route of administration for Velcade.
While, the second application seek the use of Velcade in conjunction with Rituximab in patients with relapsed follicular NHL.
Millennium chief medical officer Nancy Simonian said these two applications represent their continued commitment to further the clinical understanding of Velcade by enhancing its administration options as well as defining its utility in new cancers.
Velcade is co-developed by Millennium and Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development.
Millennium is responsible for commercialization of Velcade in the US, Janssen-Cilag is responsible for commercialization in Europe and the rest of the world.
Takeda Pharmaceutical Company and Janssen Pharmaceutical KK entered into a co-promote agreement in May 2010 for Velcade in Japan.