GEN Exclusives

More »

GEN News Highlights

More »
Jan 24, 2012

FDA Clears Subcutaneous Velcade for All Approved Indications

  • 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. 


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Tackling Climate Change

Do you think most companies will respond positively to the People’s Climate March?