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Monday, August 11, 2014

FDA Approves Velcade (Bortezomib) Retreatment for Multiple Myeloma


The U.S. Food and Drug Administration has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma who have previously received and responded to Velcade therapy and have then relapsed at least six months after the completion of that treatment.


The drug is a proteasome inhibitor that was first approved for treatment of myeloma in 2003 (OT 8/25/03 issue), and it was approved for injection in 2008 (OT 8/25/08 issue). Velcade was approved in 2006 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. And, the drug’s label was updated in 2012 to include the subcutaneous method of administration in its approved indications including multiple myeloma and mantle cell lymphoma after at least one prior therapy (OT 2/25/12 issue).


The recent actions for the drug follow data from the single arm, open-label, Phase II RETRIEVE trial of 130 patients who had previously received and responded to Velcade-based therapy and had relapsed at least six months after that prior Velcade treatment. The data showed one patient had a complete response and 49 patients had a partial response; and the median duration of response was 6.5 months.


The most common adverse effects reported in patients receiving Velcade were thrombocytopenia, diarrhea, herpes zoster, and pneumonia. Adverse reactions that led to discontinuation of treatment occurred in 13 percent of the patients. Other common side effects included fever, decreased appetite, fatigue, and rash.


Velcade is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies.