According to the company, the data supporting the FDA approval show that Treanda is effective, has a tolerable side effect profile in patients with indolent non-Hodgkin’s lymphoma (NHL) and that treatment results in a high durable response rate.
The FDA approval is supported by a pivotal study which demonstrated that patients had a high response rate to treatment with Treanda and these responses to the treatment were durable.
Lesley Russell, executive vice president and chief medical officer of Cephalon, said: “We are excited about this second FDA approval for Treanda in 2008. This approval of Treanda for indolent NHL is a significant milestone in our development of a diverse oncology portfolio of products that improve patient outcomes.”