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Cell Therapeutics launches lymphoma drug Pixuvri in Europe

Will initially be available in Sweden, Denmark and Finland

Cell Therapeutics has began a phase launch of its novel cancer drug Pixuvri in Europe that will see the non-Hodgkin B-cell lymphoma treatment debut first in Sweden, Denmark and Finland.

Conditionally approved as the first treatment in the region for adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL), Cell Therapeutics will bring it to market in Austria and Norway in October, before launching it in Germany, the UK and the Netherlands in November.

The Seattle, US headquartered biopharmaceutical firm then plans to expand the drug's availability to France, Italy and Spain and other European countries in 2013.

There are about 37,000 new cases of aggressive B-cell NHL every year in Europe, and Cell Therapeutics will look to take a strong hold in a market where few treatment options are available.

"Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," said Dr Ruth Pettengell, consultant haemato-oncologist at St George's Hospital, London and principal investigator of the phase III EXTEND study involving Pixuvri.

The EXTEND trial showed that more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed, than participants taking other active single-agent treatments.

"The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines” said Dr Pettengell. “By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."

As the drug has conditional approval in Europe, Cell Therapeutics is required to complete a post-marketing study aimed at confirming its clinical benefit.

Results from the PIX306 trial, comparing Pixuvri and Roche's MabThera (rituximab) to a regimen of Lilly's Gemzar (gemcitabine) and MabThera, are expected by June 2015 as part of this post-marketing follow-up.

Conditional marketing authorisations are granted in the EU to speed access to products that address unmet medical needs and whose availability would result in a significant public health benefit.

12th September 2012

From: Sales



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