Shares in Cell Therapeutics rocketed yesterday as investors reveled in the news that the firm has kicked off the roll out of its cancer therapy Pixuvri in Europe.
The US group’s NASDAQ-traded stock had shot up nearly 40% by mid-afternoon Tuesday after it announced that launches of the drug in Sweden, Denmark and Finland are planned for this month.
This will be followed by introductions in Austria and Norway in early October, and Germany, the UK and the Netherlands in November.
However, Pixuvri (pixatrone) won’t hit pharmacy shelves in France, Italy and Spain, and elsewhere in Europe, until next year, the firm said.
The drug won a conditional approval in Europe back in May for the treatment of adults with relapsed or refractory aggressive non-Hodgkin B-cell lymphomas, making it the first therapy given marketing clearance in the region for this group of patients.
Post-marketing study
Cell Therapeutics will initially market Pixuvri via a named patient programme, and because of the conditional approval, the firm will have to undertake a post-marketing study “aimed at confirming the clinical benefit previously observed”.
News of Pixuvri’s launch in Europe is particularly sweet for the firm, given that things are not going so well for the drug on its home turf.
The company had to withdraw its New Drug Application with US regulators after being issued with a complete response letter requested additional clinical data to support its use.
