pixantrone

The FDA is about to withdraw Avastin as a treatment for women with terminal breast cancer, and then there's a drug that most readers probably haven't heard of, called pixantrone.

The FDA and Slower Cures 2011

During the Class Period, defendants misled investors concerning the results of a Phase III clinical study ( "PIX-301") of a drug the Company was developing called pixantrone for the treatment of Non-Hodgkin's Lymphoma ( "NHL"), as well as other cancers.

TradingMarkets 2010

During the Class Period, defendants misled investors concerning the results of a Phase III clinical study ( "PIX-301") of a drug the Company was developing called pixantrone for the treatment of Non-Hodgkin's Lymphoma ( "NHL"), as well as other cancers.

TradingMarkets 2010

The real victims are the patients with no attractive options who needlessly suffer when the government delays drugs like pixantrone.

The FDA and Slower Cures 2011

As destructive, the FDA went out of its way to railroad pixantrone and make an example of the drug's maker, Cell Therapeutics, in order to send another warning to the drug industry to jump through the right bureaucratic hoops.

The FDA and Slower Cures 2011

For drugs like pixantrone, where success is less certain and budgets are limited, even large drug makers will run a single controlled trial—so that if the drug does succeed, it complies with FDA regulations.

The FDA and Slower Cures 2011

In this case, enrollment was hobbled because pixantrone wasn't a "sexy" drug—in 2004, there was minimal data about its effectiveness and thus minimal interest from U.S. oncologists or hematologists.

The FDA and Slower Cures 2011

The agency's veto came not because pixantrone failed in a clinical trial—in fact, it was a qualified success.

The FDA and Slower Cures 2011

Later, discussing a technical detail of pixantrone's trial design, he emphasized that "I think we as an oncology community have to get that point across to drug developers, because we will continually have applications with very marginal results."

The FDA and Slower Cures 2011

His excuse for rejecting pixantrone was that original Special Protocol Assessment.

The FDA and Slower Cures 2011