OBJECTIVES: In 2009, the FDA released Final Guidance on Patient-Reported Outcomes (PROs) and has stated that standards for PROs apply equally to Clinician and Observer Reported Outcomes (ClinROs, ObsROs; collectively, clinical outcome assessments - COAs).  The objective was to survey labels for oncologic drugs approved in the three years since the “PRO Guidance” was finalized and to characterize any COAs in these labels. METHODS: CenterWatch maintains a list of FDA approved drugs following definitions established by the Tufts Center for the Study of Drug Development, including only drugs or NMEs newly approved by the FDA Center for Drug Evaluation and Research.  From 2010 to the time of this review in 2013, 45 oncologic drugs were approved by the FDA.  The FDA approved product labels of each of these drugs was reviewed and each was tabulated according to its inclusion of COAs. RESULTS: Few of the approved product labels reviewed included any reference to, much less data collected using PROs, ClinROs, or ObsROs.  Several (e.g., carfilzomib) had clear statements to indicate that approval for the product was based on a predefined response rate rather than any “improvement in survival or symptoms.”  The notable exceptions are fentanyl sublingual tablets and spray and abiraterone, with PRO data on pain. CONCLUSIONS: There are several explanations for the low rate of COAs in oncology labels, especially that oncology trials tend to be unblinded.  The FDA has stated that open label designs cannot support PRO claims.  Yet there is still a heavy reliance on outcomes such as progression free and overall survival.  Three labels were identified with PRO data on pain, two of which were specifically indicated for pain rather than tumor control.  This review suggests there are opportunities for sponsors and the FDA to increase the degree to which the patient’s voice is heard during the regulatory decision making process.