Theralase Technologies Inc. V.TLT

Project FrontRunner

[ScienceFirst]

Project Fronrunner seems more suited for metastatic indication, according to this Jan. 5 paper:

The OCE at the FDA has launched Project FrontRunner to begin a discussion among stakeholders in the development of new cancer drugs on shifting the use of such therapies to an earlier timeline in the metastatic setting. The OCE intends to propose for use on a voluntary basis a framework for drug sponsors “that helps identify clinical development programs that may benefit more patients earlier in the course of their disease,” the white paper stated.

[ScienceFirst]

    Project FrontRunner  Project FrontRunner aims to shift the current oncology drug development paradigm from its typical focus on developing new therapies and gaining accelerated approval in the relapsed and refractory clinical setting, to developing therapies earlier in the clinical course of advanced/metastatic setting.