FDA Aims to Broaden Access to New Therapies.

The FDA is ramping up Project FrontRunner, which urges drugmakers to seek accelerated approval of experimental drugs as first-line treatments for patients with advanced or metastatic disease, rather than focusing on patients who have tried multiple therapies and/or exhausted available options. Experts say the program has the potential to expand access while improving the risk-benefit assessment of new drugs by initiating randomized controlled trials earlier in the drug development process.