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GEN News Highlights : Jan 24, 2012

FDA Clears Subcutaneous Velcade for All Approved Indications

Data from Phase III study confirmed noninferiority of subcutaneous versus intravenous delivery route.

FDA cleared the subcutaneous administration of Takeda’s Velcade (bortezomib) for all approved indications, which currently including multiple myeloma and mantle cell lymphoma.

The agency’s sNDA approval was based on positive data from a Phase III noninferiority study in 222 bortezomib-naive patients with relapsed multiple myeloma, which was designed to demonstrate that single agent subcutaneous Velcade retained at least 60% of the overall response rate after four cycles, relative to single agent intravenous Velcade.

Velcade is approved in over 90 countries worldwide. The drug has been codeveloped by Takeda’s Millennium, and Janssen Pharmaceutical. Millennium commercializes Velcade in the U.S., and Janssen’s responsibility covers Europe and the rest of the world. Takeda and Janssen’s Japanese businesses co-promote Velcade in Japan.