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Cephalon shows positive results for non-Hodgkin's lymphoma drug treatment

Cephalon : 23 October, 2007  (New Product)
Cephalon has announced positive results from a Phase 3 clinical trial of Treanda (bendamustine HCl) in patients with indolent non-Hodgkin's lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab.
The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.

According to the National Cancer Institute, an estimated 30,000 people in the USA will be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment.

The Phase 3, multicentre, single-arm study evaluated the efficacy and safety of single-agent Treanda in 100 patients with relapsed, rituximab-refractory NHL. The overall response rate, as assessed by an independent radiological committee, was 75 percent (p<0.0001) and the median duration of response was 40 weeks (or 9.2 months).

The overall response rate includes the percent of patients in the trial who had a complete, unconfirmed complete or partial response to treatment. The most common side effects included nausea, fatigue, neutropenia, diarrhea and vomiting. The company anticipates that the results of this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007.

'We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population,' said Dr Lesley Russell, executive vice president, worldwide medical and regulatory operations. 'Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab.'

The protocol for the NHL pivotal trial received special protocol assessment (SPA) approval from the US Food and Drug Administration (FDA) in February 2006. The SPA process allows for FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data analysis, which will be used as the basis of an efficacy claim to support a New Drug Application (NDA).

In September 2007, Cephalon submitted an NDA requesting approval of Treanda for the treatment of patients with chronic lymphocytic leukaemia (CLL), for which the FDA has granted orphan drug status.
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