Pharmalot On Quick Approval of Cancer Drugs
The FDA is approving cancer drugs at a very fast pace when compared to other drugs, writes Ed Silverman in Pharmalot. A very interesting article indeed which brings to notice the time taken by FDA while approving cancer meds as well as the fact that FDA approves cancer drugs faster than European regulators according to data from Tufts Center for the Study of Drug Development.
FDA OKs Cancer Drugs Faster Than Other Meds
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.
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