FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multip...( - New indication offers earlier...),Health

- New indication offers earlier treatment options for patients -

CAMBRIDGE, Mass. and OSAKA, Japan, June 20 /PRNewswire/ -- Millennium Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) today announced that the U.S. Food and Drug Administration (FDA) approved VELCADE for patients with previously untreated multiple myeloma (MM). The Company's co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) also has filed a corresponding application with the European Medicines Evaluation Agency (EMEA).

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(Logo: http://www.newscom.com/cgi-bin/prnh/20080620/NEF058LOGO-b )

"This comes as wonderful news for patients. The VISTA(1) trial showed 30% complete remission rate with bortezomib compared to 4% for the control arm. Importantly, patients treated with bortezomib also experienced a survival benefit," said Paul Richardson, M.D., a senior investigator for the study and Clinical Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.

"We are excited for patients with previously untreated multiple myeloma, who now can benefit from VELCADE, including its ability to deliver a significant increase in overall survival. VELCADE treatment also is available for multiple myeloma patients in the second- and third-line settings, where it already is approved," said Deborah Dunsire, M.D., President and CEO, Millennium Pharmaceuticals, The Takeda Oncology Company.

The current approval was based on an international, multicenter, open label, active-control trial in previously untreated patients with symptomatic multiple myeloma. Patients were randomized to receive either nine 6 week cy
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