Cephalon has won another US approval for its chemotherapy drug Treanda, this time as a treatment for non-Hodgkin's lymphoma.

Specifically, the US Food and Administration has given the go-ahead for Treanda (bendamustine) for the treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with Rituxan (rituximab) or a rituximab-containing regimen. The drug was approved in March by the agency as a treatment for chronic lymphocytic leukaemia, the most common form of the disease.

The FDA approval is supported by a pivotal trial of 100 patients with indolent B-cell NHL who had a high response rate to treatment with Treanda, and these were durable. Treatment with the drug as a single agent resulted in an overall response rate of 74%, which means that after treatment, “the cancer diminished or disappeared in approximately three out of four patients”, Cephalon noted. 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 9.3 months.

The firm’s chief medical officer, Lesley Russell, said “we are excited about this second FDA approval for Treanda in 2008”. It is “a significant milestone in our development of a diverse oncology portfolio of products that improve patient outcomes", she added.

Cephalon reported $24.6 million in sales for Treanda in the third quarter, up 71%. The drug is seen as vital to the firm’s future as patent protection on its flagship blockbuster sleep drug Provigil (modafinil), which brings in a large chunk of the group’s revenues, runs out in 2012.