FDA Boasts About Approvals Of Cancer Drugs
1 CommentBy Ed Silverman // February 19th, 2010 // 8:24 am
In a bid to tout its accomplishments, the FDA is trumpeting a new study showing the agency approved more than 50 new indications for cancer and hematology meds and biologics between July 2005, when the Office of Oncology Drug Products began reviewing marketing applications, and July 2007. And during that stretch, the OCD also reviewed 60 applications for meds to treat all sorts of cancer (see statement).
The OCD acted on 58 of the applications, approving 53 new cancer indications. Five were not approved, and two were withdrawn before any regulatory action was taken. The approved applications included indications for 18 new drugs that hadn’t been previously approved and 35 added indications for already approved drugs. Here is the abstract of the study in the Journal of the National Cancer Institute.
Other points the FDA highlighted: new drugs were approved for six of the seven most deadly type of cancer in the US (lung, colon, breast, ovarian, cervical and pancreatic); 35 approvals were existing meds seeking new indications; new molecular entities represented 18, or 34 percent, of the 53 approvals; approvals included treatments for kids, supportive care indications aimed at improving side effects of cancer meds, and treatment options for rare diseases; nine drugs received accelerated approval, and 25 percent of approved indications were based on improvement in overall survival or improvement in both progression-free survival and overall survival. We anticipate, of course, that advocates for the Provenge vaccine from Dendreon will say the med should have been on the list.
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According to study findings presented at a June 2007 annual ASCO meeting, given the scarcity of both money and willing volunteers for cancer research, a phase II trial shouldn’t even be started unless there is an intention to take it forward, if the phase II results look promising. An overabundance of phase II trials presented at ASCO and other meetings that claimed promising results but then went nowhere. Most of the trials reached a dead end because the researchers couldn’t get financial backing or enough patients for a phase III look at the treatment.
There are a lot of young oncologists out there and they are encouraged to publish. Their promotion at academic centers is dependent on publication. So many of them may be encouraged to put together a protocol in which they take new drugs and treat a small number of patients with a certain disease in a phase II trial. A young researcher is more likely to be listed as the prestigious “lead” researcher. This gains researchers more recognition.
And at the 2009 ASCO Breast Cancer Symposium, a keynote speaker made a point that 92% of new drugs entering phase I trials never make it to marketing and this percentage is even higher for cancer drugs, because current drug testing is inefficient, with many drugs failing late in development, with these failures owing, in large measure, to ineffective drugs and poor patient selection (lack of prognostic and predictive markers for response to therapy).