This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.   It also provides background information and discusses general regulatory principles.  The endpoints discussed in this guidance are for drugs to treat patients with an existing cancer.   This guidance does not address endpoints for drugs to prevent or decrease the incidence of cancer.

This guidance is a revision of the final guidance of the same title that published in May 2007.  This guidance replaces the May 2007 guidance of the same title.  

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.