"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."
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