OBJECTIVES: The US Food and Drug Administration (FDA) did not approve any PRO label claims for cancer treatments between 2006 and 2010. In December 2009, the agency published guidance on the use of PROs to support label claims, and in 2012 the Center for Medical Technology Policy (CMTP) called for all prospective comparative studies of oncology drugs in adults to include PRO measures. The current study sought to identify how many PRO claims have been approved since the publication of these documents, to consider the challenges for sponsors seeking such claims, and offer solutions to these challenges. METHODS: The FDA website was searched for approvals of hematology and oncology drugs 2010–2014. The most recently approved labels of eligible products and drug approval packages were reviewed for comments on PRO data. RESULTS: Of 64 drug labels suitable for review, two had PRO efficacy claims: ruxolitinib (myelofibrosis) was claimed to improve symptoms, as measured by the Myelofibrosis Symptom Assessment Form; abiraterone acetate (prostate cancer) was claimed to improve pain, as measured by the Brief Pain Inventory (BPI-SF). For crizotinib (NSCLC), PROs were used to support adverse event reporting (vision disorders). The label for brentuximab stated that no improvement in patient-reported symptoms for either indication (Hodgkin lymphoma and anaplastic large cell lymphoma) had been established. A further 12 labels stated that there were no data to demonstrate improvement in disease-related symptoms. CONCLUSIONS: This review demonstrates the emergence of PRO label claims for oncology products, despite the recent FDA and CMTP guidance PRO data are infrequently documented in FDA-approved oncology labels.  Labels increasingly specify when there is an absence of symptom data e.g. brentuximab, carfilzomib, marking a shift in FDAs expectations. Sponsors face challenges such as a lack of validated tumor-specific instruments. A strategic four-step PRO endpoint development process provides a way forward.