Landmark Trial for Personalized Medicine Coming Soon: NGS Approval May Be One Offshoot of Lung Cancer “Master Protocol”
This article was originally published in RPM Report
A Friends of Cancer Research/Brookings proposal for a multi-drug, multi-sponsor registrational study of targeted cancer drugs is moving forward. Squamous cell lung cancer will be the initial indication. If successful, the study could lead to rapid final development of several targeted therapies, a potential route to FDA approval of NextGen Sequencing in oncology—and broad adoption of the “master protocol” model.
You may also be interested in...
An Institute of Medicine workshop on companion diagnostics suggests that regulatory standards are evolving at FDA to encourage companion diagnostic development. But almost everything else is still a challenge.
FDA Eager For More Master Protocols in Oncology: Approach Means Lower Cost For Sponsors—and Less Control
FDA officials are enthusiastic about broad, multi-agent cancer trials built on the I-SPY model. For sponsors, the trials mean less control over the development path and ultimate value proposition for the therapy—but may have important benefits on defending high prices for truly effective new therapies.
Debate at a recent cancer research meeting reflects the challenges that lay ahead, and the diverging viewpoints that will have to be balanced, in creating any new approval mechanism.