Celebrating good works and waiting . . . for good news.

Ken Hatch, Dr. Jim Bianco, Mike Kunath

Yesterday, celebrating the success of the recent Gilda's Club Seattle fundraiser at the Chihuly Boathouse, three of the steering committee members, Mike Kunath, Ken Hatch and Dr. Jim Bianco, got together for a drink at the Fairmont Olympic.  See my previous blog post about the event HERE. 

Jim Bianco with WSJ article.

The three also discussed the recent good news from The U.S. Food and Drug Administration's Office of New Drugs to Cell Therapeutics Inc. regarding the company's cancer drug, pixantrone.  Mike and Ken presented to Jim a framed copy of a February 28, 2011 article from the Wall Street Journal entitled, "FDA and Slower Cures" which talked about the FDA being an agency that "cares more about its regulatory prerogatives than about the thousands of patients who might benefit and will die waiting".

And more from that WSJ article, "In May 2010, the FDA rejected pixantrone for treating non-Hodgkin's lymphoma, a blood cancer that kills nearly 12,000 Americans a year. The agency's veto came not because pixantrone failed in a clinical trial—in fact, it was a qualified success. Instead, the FDA determined that the trial was not "flawlessly executed," as its regulations demand.

And continuing, "If perfection is the standard for new cancer drugs, then we may as well give up hope of ever getting another one. 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."

Though the initial ruling from a lower division of the FDA in 2010 was negative, Jim said he thinks that the news from the higher divison of the FDA was unprecedented and said that the accelerated approval of pixantrone may not necessarily be out of reach based on a single controlled clinical trial, once two key matters can be satisfactorily resolved; both of which he believes could be resolved soon and the requested information is submitted.  Under the guidelines, the FDA must render a decision within six months from when the new drug application was resubmitted to FDA which could result in the drug’s approval early next year.

For the sake of non-Hodgkin's lymphoma cancer sufferers, my fingers are crossed for a speedy approval this time.