Cell Therapeutics has won conditional approval in Europe for its lymphoma drug Pixuvri.
The European Commission has given the green light to Pixuvri (pixantrone) as monotherapy for the treatment of adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas, making it the first approved treatment in this patient setting in the continent. The decision covers the 27 member states of the European Union, plus Iceland, Liechtenstein and Norway.
Cell Therapeutics will market Pixuvri initially through a named patient programme and through the conditional marketing authorisation, renewable annually, the company will be required to complete a post-marketing study "aimed at confirming the clinical benefit previously observed". The EU approval is based on a Phase III trial which demonstrated that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy (20% versus 6%) and patients on the drug survived for longer without their disease progressing (an average of 10.2 months versus 7.6 months).
The thumbs-up is a major boost for Cell Therapeutics, which withdrew its New Drug Application in the USA in January. In April 2010, the Food and Drug Administration issued a complete response letter to the company saying it should conduct an additional clinical trial on Pixuvri and a month earlier, the agency's Oncologic Drugs Advisory Committee voted 9-0 against recommending approval.
Cell Therapeutics will market Pixuvri with its own sales force in Europe starting in the second half.