According to Dr. Lesley Russell, Executive Vice President and Chief Medical Officer, Cephalon, "We are excited about this second FDA approval for TREANDA in 2008. This approval of TREANDA for indolent non-Hodgkin's lymphoma is a significant milestone in our development of a diverse oncology portfolio of products that improve patient outcomes."
The FDA approval is supported by a pivotal trial of 100 patients with indolent B-cell NHL who had progressed during or within six months of treatment with a regimen that included rituximab. The pivotal study demonstrated that patients had a high response rate to treatment with TREANDA, and these responses to the treatment were durable. The results from the pivotal study showed that treatment with Treanda as a single agent resulted in an overall response rate of 74 percent, which means that after treatment, the cancer diminished or disappeared in approximately three out of four patients. Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months and patients remained alive and their disease did not progress for a median of 9.3 months.
The safety of TREANDA is also supported by a secondary monotherapy study. In the pivotal and secondary studies for TREANDA in indolent NHL, the most common non-hematologic adverse reactions (frequency greater than or equal to;15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decrease, dyspnea, rash and stomatitis. The most common hematologic abnormalities (frequency greater than or equal to;15%) are lymphopenia, leukopenia, anemia, thrombocytopenia and neutropenia.
In addition to its proven efficacy and tolerable side effect profile,
TREANDA has a convenient dosing schedule as a treatment for indolent NHL.
An intravenous infusion takes 60 minutes and can be administered in an
outpatient setting, reducing the time it takes for patients to be treated.
The recommended dos
|SOURCE Cephalon, Inc.|
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