The proportion of U.S. men with early, slow-growing prostate cancer who received robotic surgery and other expensive treatments increased between 2004 and 2009, according to a new study. Researchers found that use of those therapies also rose among men who were unlikely to die from prostate cancer because they were sick with other chronic diseases…
Maybe more than any other person alive, Richard Pazdur, the director of the Food and Drug Administration’s Office of Oncology and Hematology Products, personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first. To his critics, he is an…
In the push to match medical therapies to the genetic underpinnings of disease, lung-cancer treatments have been at the frontier. But the 1.6 million people diagnosed with this cancer every year will take scant comfort in knowing that of the past 20 late-stage trials of drugs to treat it, only two yielded positive results. And in…
FDA appears to be acting more like a development partner than a regulator in dealing with a “breakthrough” therapy designee, based on the experience of one sponsor. “You actually can go in and ask for clarity on what’s expected,” Kunkel said. Pharmacyclics Inc. Chief Medical Officer Lori Kunkel said early discussions about ibrutinib, which holds…
When Douglas Alexander’s prostate cancer showed signs of re-emerging after years in remission, he didn’t have any viable treatment options available. The radiation therapy he’d had when he was first diagnosed with a stage I tumor five years earlier couldn’t be repeated, and surgery also wasn’t an option: Despite rising levels of prostate-specific antigen (PSA),…
CHICAGO—In the eyes of Richard Pazdur, a breakthrough cancer drug should be “transformative.” His view is important because Dr. Pazdur is the head of the U.S. Food and Drug Administration’s office of hematology and oncology products, which helps decide whether experimental cancer drugs are sufficiently safe and effective to go on the market. Under a…
A new regulatory pathway established last year allows drugs with dramatic early clinical promise to be expedited to the market quicker than ever before. To date, most of these ‘breakthrough’ designations have gone to cancer agents, raising the prospect of faster access to the latest lifesaving therapies for the estimated 4,500 people newly diagnosed with…
CHICAGO–The FDA’s oncology chief, Richard Pazdur, used his turn in front of the press mob at ASCO today to make some very public vows about his commitment to the newly launched breakthrough-drug program, that intriguing new classification for certain stellar therapeutic programs that will be extended VIP status at the agency. Pazdur stressed that any…
Whether she’s tackling the complexities of science or style, the medical philanthropist, fashion icon and social mover Deeda Blair approaches all facets of life with quiet but unwavering discipline. Slide Show Most scientists are astonished by Deeda Blair’s style, and the style mavens are surprised by her scientific expertise. That is obvious to even the…
The FDA has added another regulatory coup for Alexion’s ($ALXN) late-stage program for asfotase alfa, an enzyme replacement therapy for extremely rare cases of a metabolic disease known as hypophosphatasia. Already handed an orphan drug designation alongside fast-track status, the agency has added the highly sought after “breakthrough drug” designation for the therapy, which could…
