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News

Cephalon submits NDA for new CLL treatment

Cephalon : 21 September, 2007  (New Product)
Cephalon has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting approval of Treanda (bendamustine HCl) for the treatment of patients with chronic lymphocytic leukaemia (CLL).
If approved, Treanda would be the first new therapy approved by the FDA for the treatment of CLL since 2001. In August 2007, the FDA granted orphan drug designation to Treanda for this indication.

'This is our first regulatory filing for Treanda and a significant milestone for our growing oncology portfolio,' said Dr Lesley Russell, executive vice president, worldwide medical and regulatory operations. 'We also are developing Treanda for the treatment of non-Hodgkin's lymphoma and are planning additional submissions for Cephalon oncology compounds to the FDA over the next 12 months.'

The NDA is based on a large, international multi-centre Phase 3 clinical trial that evaluated the safety and efficacy of bendamustine HCl, the active ingredient in Treanda, compared to chlorambucil in patients who were not previously treated for their disease. Chlorambucil is an FDA-approved first-line therapy for patients with CLL.

In the pivotal trial, bendamustine HCl met both primary endpoints, overall response and progression-free survival and demonstrated an acceptable tolerability profile. The company anticipates that results from this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007.

The company also is studying Treanda for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (NHL), who are refractory to the monoclonal antibody rituximab. Pending positive results from this ongoing study, the company anticipates filing an NDA for Treanda in patients with indolent NHL who are refractory to rituximab in the fourth quarter of 2007.

In addition, Cephalon is studying Treanda in combination with rituximab in patients with relapsed indolent and mantle cell NHL. The company anticipates that results from studies of Treanda as monotherapy and in combination will be presented at medical meetings later this year.
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