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 cancer each day in the US. Elie Dolgin looks at what sets these breakthrough medicines apart.
In March 2012, a congressional briefing was held on Capitol Hill to discuss the prospects of a new development pathway for the US Food and Drug Administration (FDA). The facilitator, a local advocacy organization called Friends of Cancer Research (FOCR), trotted out an oncology expert, a healthcare investor and current and former FDA officials, all to make the case that experimental drugs that produce large and unprecedented treatment effects in early-phase clinical trials were not reaching the market fast enough….
