FDA OKs Cancer Drugs Faster Than Other Meds // Pharmalot

For those banking on new cancer treatments becoming available in the US, a new analysis should offer some encouragement. The FDA, it turns out, approves cancer drugs faster than medications for other ailments. What?s more, the FDA approves cancer drugs faster than European regulators as well, according to the Tufts Center for the Study of Drug Development.

Specifically, FDA approval times for cancer meds between 2007 and 2011 took 10 months less than for other drugs, while approval times by the European Medicines Agency took two months less time, Tufts reports. Looked at another way, the EMA took 54 percent more time to approve cancer meds, although the EMA took 27 percent less time to approve other drugs. Cancer drugs as a share of total approvals at the FDA and the EMA were 19 percent and 12 percent, respectively.

Meanwhile, orphan designations for cancer meds in the US rose during the past decade, but the share of fast track and accelerated approval designations dropped sharply (see chart). Between 2007 and 2011, 39 percent of FDA orphan approvals were for oncology drugs, up from 31 percent between 2002 and 2006, Tufts writes. Similarly, 37 percent of EMA orphan approvals were for cancer meds between 2007 and 2011, up from 28 percent during the earlier part of the decade.

However, designation status had little impact on cancer drug approval times between 2007 and 2011. FDA approval times for all meds were about half those of the EMA, regardless of designation. But within each agency, approval times for cancer meds were similar, with just a 13 percent and 1 percent difference, at the EMA and FDA respectively, depending on designation. Yet in Europe, cancer approvals with orphan status during the past decade rose from 35 percent to 45 percent, according to Tufts (here is the statement).

Meanwhile, total development time for new molecular entities and biological license applications for all approvals in the US was eight years between 2002 and 2006, but 7.4 years between 2007 and 2011. And as noted, approval times for cancer meds were 10 months shorter. Why? The likelihood that developing cancer meds mean relying on smaller patient populations and longer periods in which to evaluate patient responses, Tufts writes.

Overall, total development time for all new meds shortened during the past decade. Between 2002 and 2006 in the US, total development time for oncology new biological entity took nearly two years longer than non-oncology NBEs ? 8.9 vs. 7.0 years. And total development time for oncology new chemical entities took about six months less than non-oncology approvals ? 7.6 vs. 8.0 years, Tufts writes in its analysis.

Between 2007 and 2011, total development times for oncology and non-oncology NBEs were both about 6.4 years and 7.6 years for oncology and non-oncology NCEs. During the past decade, Tufts finds that total development time for oncology NBEs dropped by 2.5 years, while for NCEs it remained about the same. Among non-cancer meds, both NBEs and NCEs were about six months faster.

Source: http://www.pharmalot.com/2012/09/fda-oks-cancer-drugs-faster-than-other-meds/

Helen Gurley Brown Kathi Goertzen