USA – FDA approvals of new cancer drugs have doubled in this decade

n the 1980s, only 4% of new drugs approved by the FDA were cancer treatments. But since 2010, cancer drugs have claimed 27% of new approvals—a share that doubled over the previous decade—according to a new report from the Tufts Center for the Study of Drug Development.

Why the surge in oncology successes? Because pharmaceutical companies have taken a new approach to drug development, focusing on pursuing novel mechanisms for treating cancer and validating them with clinical trials that are much better designed than they were in the past.

Couple that with an FDA that has doubled down on its efforts to speed medicines to market that address unmet medical needs, and the result is a flood of new cancer drugs, the Tufts report concluded.

According to Tufts, the development timeline for cancer drugs was 9% longer than it was in other diseases between 1999 and 2018, but the time it took for the FDA to approve cancer drugs was a whopping 48% shorter on average. That’s because new oncology products were far more likely to receive special designations from the FDA designed to speed up the regulatory process, including orphan drug designations and priority reviews, according to a summary (PDF) of the Tufts report…