The FDA ( Food and Drug Administration ) has approved Velcade ( Bortezomib ) for the treatment of patients with mantle cell lymphoma ( MCL ) who have received at least one prior therapy.
Mantle cell lymphoma is a relatively uncommon and aggressive form of non-Hodgkin's lymphoma for which there was no standard of care in the relapsed or refractory setting.
Mantle cell lymphoma has a U.S. prevalence of 10,000 patients.
The approval is based on data from the PINNACLE trial, the largest study to date in patients with mantle cell lymphoma.
PINNACLE was a prospective, multi-center, single-arm, open-label study in patients with mantle cell lymphoma whose disease progressed following at least one prior therapy. Response rates to Bortezomib were determined according to the International Workshop Response Criteria ( IWRC ) and based on independent radiologic review of CT scans.
Results of the study, which formed the basis of the approval, include:
- overall response rate of 31 percent;
- complete response ( CR + Cru ) rate of 8 percent ;
- median duration of response of 9.3 months; 15.4 months in patients achieving a complete response;
- median time to progression of 6.2 months
In PINNACLE, the most commonly reported adverse events were asthenic conditions ( 72% ), peripheral neuropathy ( 55% ), constipation ( 50% ), diarrhea ( 47% ), nausea ( 44% ), decreased appetite ( 39% ), rash ( 28% ), edema ( 28% ), vomiting ( 27% ), dizziness ( 23% ), dyspnea ( 23% ), insomnia ( 21% ) and thrombocytopenia ( 21% ).
Velcade is also approved for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Source: FDA, 2006
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