FDA Disapproves Pixantrone, Cell Therapeutics in Difficulty
Abstract:An advisory panel of the U.S. Food and Drug Administration has shown red signal to pixantrone as it failed to impress them.
The panelists unanimously agreed on the fact Pixantrone, Cell Therapeutics' (CTIC) lymphoma therapy, does not have adequate clinical data to support approval of the drug.
Single Clinical Trial – Was that enough for Pixantrone?
According to the Oncologic Drugs Advisory Committee, single that too an incomplete trail was not enough proof for the effectiveness of pixantrone in treating refractory aggressive non-Hodgkin's lymphoma.
Moreover, clinical trial done by the Cell Therapeutics managed to get only 140 out of 320 participants for clinical trial of the medicine.
Next Step for Cell Therapeutics
James Bianco, CEO of Cell Therapeutics said his company is “committed to working closely with the FDA to address the committee's comments as quickly as we can."
However, starting the process once again may not be very easy for Cell Therapeutics as generating new data to get approval from FDA will be a time consuming affair and will cost millions. Moreover, the company is already running on loss of $1.4 billion (as of December 31, 2009). Additionally, Novartis, its partner on the drug, is also withholding its option to license the drug, an event that would have delivered as much as $104 million in registration and sales milestones. Therefore, chance of Pixantrone to release soon is still in doubt.
Source:
http://seekingalpha.com/article/195948-fda-likely-to-deliver-blow-to-cell-therapeutics?source=feed
