On December 15, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance for industry entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease”. This draft guidance describes:
- The FDA’s current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials thereby increasing the likelihood of finding viable treatment options for those with less common alterations; and
- General approaches to evaluate the benefits and risks of targeted therapies within a clinically defined disease where some molecular alterations may occur at low frequencies which could lead to more consistent development and approval of targeted therapies for patients who are likely to benefit from them.
The “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” draft guidance is available at https://go.usa.gov/xnQvb. Please refer to the guidance for more details.
FDA is publishing this draft guidance to collect public comments. You may submit your comments to this guidance by February 16, 2018 to the Docket No. FDA-2017-D-6617 available athttps://www.regulations.gov. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience, and make your voice count.