Women ill-informed about lung cancer potential
A new national poll shows that American women show little concern about developing lung cancer, despite the fact that it is the number one cancer killer of women. Lung cancer will kill more than 70,000 women this year – more than breast cancer (about 41,000) and ovarian cancer (about 15,000) combined.
Lung cancer death rates for U.S. women are among the highest in the world. The poll was commissioned by Cell Therapeutics (Seattle).
During the past 20 years, lung cancer deaths among women increased nearly 200%, while the number for men decreased about 5%. Yet women are even less worried than men about developing lung cancer.
According to the survey, 45% of women were more concerned about having a heart attack, while 33% pointed to breast cancer as their number one health fear. Only 11% said lung cancer worried them despite recent news coverage of the high profile celebrity deaths of Dana Reeve and Peter Jennings. The poll, conducted by Public Opinion Strategies (Alexandria, Virginia) included 800 likely voters with equal numbers of men and women. n
Cordis applies to FDA for direct stenting
Cordis (Miami) said that it has filed a premarket approval supplement (PMA) with the FDA to include language in the instructions for use (IFU) about direct stenting of the Cypher (sirolimus-eluting coronary stent). Direct stenting is the placement of a stent without balloon pre-dilatation.
The foundation for the PMA is data from the DIRECT Stent Trial, a multicenter, prospective, non-randomized study of 225 patients. The trial compared the results of direct stenting to those obtained using conventional balloon pre-dilatation from the previously reported SIRIUS trial. n
Biosite withdraws PMA for stroke panel
Biosite (San Diego) said that it intends to voluntarily withdraw its premarket approval (PMA) application for the Triage Stroke Panel, currently on hold with the FDA. As previously disclosed by the company, Biosite also intends to begin planning for an additional clinical study to potentially support a new U.S. regulatory submission for the product.
The company originally submitted the PMA for the Triage Stroke Panel to the FDA in January 2005, and had been preparing to submit additional information to the FDA for the pending PMA.
“Withdrawing the PMA submission will allow us the time and flexibility to tailor a clinical trial strategy that improves the prospects for U.S. regulatory approval and commercial success of the Triage Stroke Panel,” said Kim Blickenstaff, chairman and CEO. “We believe that continuing with the existing PMA would have been a lengthy process requiring the commitment of significant energy and resources, both at Biosite and the FDA. For Biosite, these resources can now be applied more efficiently across our entire pipeline of potential new products, including the Triage Stroke Panel.”